FDA 510(k) Applications for Medical Device:
Kit, Test, Pregnancy, Hcg, Over The Counter
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K981892 | ABACUS DIAGNOSTICS |
6520 PLATT AVE., #220 | WEST HILLS | CA | 91307 |
| K970082 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. D49C | ABBOTT PARK | IL | 60064-3500 |
| K990373 | ABBOTT LABORATORIES |
DEPT 49C, BLDG. AP31 | ABBOTT PARK | IL | 60064-3537 |
| K032159 | ACCESS BIO INCORPORATE |
675 US HIGHWAY 1 | NORTH BRUNSWICK | NJ | 08902 |
| K234152 | Aceso Laboratories, Inc. |
14020 Central Avenue, Suite 520 | Chino | CA | 91710 |
| K193318 | Acon Laboratories Inc. |
5850 Oberlin Drive #340 | San Diego | CA | 92121 |
| K050546 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K983090 | ACON LABORATORIES, INC. |
3140-B TILGHMAN ST. | ALLENTOWN | PA | 18104 |
| K993483 | ACON LABORATORIES, INC. |
11175 FLINTKOTE AVE., #F | SAN DIEGO | CA | 92121 |
| K032661 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K033041 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K032510 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K042151 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K232715 | ACON Laboratories, Inc. |
5850 Oberlin Drive, #340 | San Diego | CA | 92121 |
| K012215 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K172512 | ACRO Biotech, Inc. |
9500 Seventh Street, Suite M | Rancho Cucamonga | CA | 91730 |
| K180771 | ACRO Biotech, Inc. |
9500 Seventh Street, Suite M | Rancho Cucamonga | CA | 91730 |
| K023037 | ADVANCED DIAGNOSTICS, INC. |
801 MONTROSE AVE. | SO. PLAINFIELD | NJ | 07080 |
| K062703 | AI DE DIAGNOSTIC CO., LTD. |
1929 WOODBERRY COURT | IOWA CITY | IA | 52246 |
| K984075 | ALFA SCIENTIFIC DESIGNS, INC. |
11494 SORRENTO VALLEY RD., | SAN DIEGO | CA | 92121 |
| K023126 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K031271 | AMERISOURCE PHARMACAL, INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K953606 | AMERITEK, INC. |
7030 35TH AVE., N.E. | SEATTLE | WA | 98115 |
| K241394 | Andon Health Co., Ltd. |
No 3, Jinping Street, Ya An Road, Nankai District | Tianjin | ||
| K240242 | Anhui DEEPBLUE Medical Technology Co. LTD. |
No.777 Jimingshan Road, High-Tech Development Zone | Hefei | 230088 | |
| K053138 | ANI BIOTECH OY |
163 CABOT STREET | BEVERLY | MA | 01915 |
| K040866 | ARMKEL LLC |
469 NORTH HARRISON STREET | PRINCETON | NJ | 08543 |
| K973352 | ARMKEL, LLC. |
HALF ACRE RD. | CRANBURY | NJ | 08512-0181 |
| K962183 | ARMKEL, LLC. |
HALF ACRE RD. | CRANBURY | NJ | 08512-0181 |
| K992232 | ARMKEL, LLC. |
HALF ACRE RD. | CRANBURY | NJ | 08512 |
| K030258 | ARMKEL, LLC. |
469 NORTH HARRISON ST. | PRINCETON | NJ | 08540-3510 |
| K961712 | ARMKEL, LLC. |
HALF ACRE RD. | CRANBURY | NJ | 08512 |
| K060019 | ARTRON LABORATORIES, INC. |
3938 NORTH FRASER WAY | BURNABY, BRITISH COLUMBIA | V5J 5H6 | |
| K233174 | Assure Tech (Hangzhou) Co., Ltd. |
2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road | Hangzhou | 310011 | |
| K243573 | Assure Tech LLC |
1521 Concord Pike, Suite 201 | Wilmington | DE | 19803 |
| K250117 | Assure Tech LLC |
1521 Concord Pike, Suite 201 | Wilmington | DE | 19803 |
| K962888 | ATHENA MEDICAL CORP. |
10180 S.W. NIMBUS AVE. | PORTLAND | OR | 97223-4340 |
| K203246 | Atlas Link Technology Co., Ltd. |
Gu'an South Industry Zone | Langfang | 065500 | |
| K102760 | ATLAS MEDICAL |
KING ABDULLAH II INDUS. ESTATE | AMMAN | 11512 | |
| K041748 | AZOG, INC. |
1011 US HWY 22 | PHILLIPSBURG | NJ | 08865 |
| K053452 | BIO FOCUS CO., LT. |
251E. REDONDO BEACH BLVD. | GARDENA | CA | 90248 |
| K970008 | BIONIKE, INC. |
1015 GRANDVIEW DR. | SOUTH SAN FRANCISCO | CA | 94080-4910 |
| K050305 | BIOSCREEN MEDICAL INC. |
RR I BOX 1045A | MILDRED | PA | 18632 |
| K032992 | BIOTECH ATLANTIC, INC. |
BAY F, 6 INDUSTRIAL WAY WEST | EATONTOWN | NJ | 07724 |
| K960174 | BIOTECH ATLANTIC, INC. |
BAY F, 6 INDUSTRIAL WAY WEST | EATONTOWN | NJ | 07724 |
| K071930 | BLUE CROSS BIO-MEDICAL CO., LTD. |
BEIQIJA INDUSTRY ZONE | BEIJING | 102209 | |
| K013907 | CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
MERVUE BUSINESS PARK | GALWAY | ||
| K955903 | CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
MERVUE BUSINESS PARK | GALWAY | ||
| K030533 | CENOGENICS CORP. |
100 RT. 520 | MORGANVILLE | NJ | 07751 |
| K011551 | Chembio Diagnostic Systems, Inc. |
163 CABOT ST. | BEVERLY, | MA | 01915 |
| K961965 | Chembio Diagnostic Systems, Inc. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K131931 | CHEMTRON BIOTECH, INC. |
8370 JUNIPER CREEK LANE | SAN DIEGO | CA | 92126 |
| K123436 | CHURCH & DWIGHT CO., INC. |
469 NORTH HARRISON STREET | PRINCETON | NJ | 08543 |
| K083716 | CHURCH & DWIGHT CO., INC. |
469 NORTH HARRISON STREET | PRINCETON | NJ | 08543 |
| K070054 | CHURCH & DWIGHT CO., INC. |
469 NORTH HARRISON STREET | PRINCETON | NJ | 08543 |
| K123567 | CHURCH & DWIGHT CO., INC. |
469 NORTH HARRISON STREET | PRINCETON | NJ | 08543 |
| K132085 | CO-INNOVATION BIOTECH CO., LTD. |
NO. 13 YANYUAN ROAD. TIANHE DISTRICT | GUANGZHOU, GUANGDONG | 510507 | |
| K213808 | Co-Innovation Biotech Co.,Ltd. |
No. 9 Baihe 3 Street, | Guangzhou | 510507 | |
| K150063 | Coretests, Inc. |
6190 Yarrow Drive | Carlsbad | CA | 92011 |
| K964108 | DIRECT ACCESS DIAGNOSTICS |
440 RT. 22 EAST | BRIDGEWATER | NJ | 08807 |
| K962521 | DIRECT ACCESS DIAGNOSTICS |
440 RT. 22 EAST | BRIDGEWATER | NJ | 08807 |
| K971286 | EXCEL SCIENTIFIC, INC. |
23071 LA PALMA AVE. | YORBA LINDA | CA | 92887 |
| K962580 | EXCEL SCIENTIFIC, INC. |
23071 LA PALMA AVE. | YORBA LINDA | CA | 92887 |
| K970425 | EXCEL SCIENTIFIC, INC. |
23071 LA PALMA AVE. | YORBA LINDA | CA | 92887 |
| K991369 | GERMAINE LABORATORIES, INC. |
4203 GARDENDALE CENTER, #230 | SAN ANTONIO | TX | 78229 |
| K222305 | Guangzhou Decheng Biotechnology Co. Ltd. |
Room 107/218/212/405, Building 2, No. 68, 1st Nanxiang Road | Guangzhou | 510000 | |
| K240643 | Guangzhou Decheng Biotechnology Co., Ltd. |
Room 107/218/212/405, Building 2, No. 68, 1st Nanxiang Road | Guangzhou | 510000 | |
| K230038 | Guangzhou Decheng Biotechnology Co., Ltd. |
Room 107/218/212/405, Building 2, No. 68 | Guangzhou | 510000 | |
| K043443 | Guangzhou Wondfo Biotech Co., Ltd. |
8903 SPRUCE MILL DRIVE | YARDLEY | PA | 19087 |
| K173229 | Guangzhou Wondfo Biotech Co., Ltd. |
No.8 Lizhishan Road, Science City | Guangzhou | 510641 | |
| K150022 | Guangzhou Wondfo Biotech Co., Ltd. |
Wondfo Scientech Park, South China Univ. of technology | Guangzhou | 510641 | |
| K233624 | Hangzhou Aichek Medical Technology Co., Ltd. |
3rd Floor, Building 9, Hexiang Technology Center, | Hangzhou | 310018 | |
| K241978 | Hangzhou AllTest Biotech Co., Ltd. |
No. 550 Yinhai Street | Hangzhou | 310018 | |
| K251053 | Hangzhou AllTest Biotech Co., Ltd. |
No. 550 Yinhai Street | Hangzhou | 310018 | |
| K193132 | Hangzhou Clongene Biotech Co.,Ltd. |
Building 4, No.20 Longquan Road, Yuhang District | Hangzhou | 311121 | |
| K212447 | Hangzhou Sejoy Electronics & Instruments Co., Ltd. |
Area C, Building 2, No.365 | Hangzhou | 311100 | |
| K123703 | HEALGEN SCIENTIFIC, LLC |
3818 FUQUA STREET | HOUSTON | TX | 77401 |
| K212418 | Healstone Biotech Inc. |
Unit 650, 655 West Kent Ave. N., | Vancouver | V6P 6 | |
| K023638 | IND DIAGNOSTIC INC. |
1629 FOSTERS WAY | DELTA, BC | V3M 6S7 | |
| K110889 | IND DIAGNOSTICS INC. |
1629 FOSTERS WAY | DELTA, BRITISH COLUMBIA | V3M 6S7 | |
| K192843 | Innovita (Tangshan) Biological Technology Co., Ltd |
No. 699 Juxin Street, High-tech Industrial Development Zone | Qian'an | 064400 | |
| K974059 | INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
1629 FOSTERS WAY | DELTA, BRITISH COLUMBIA | V3M 6S7 | |
| K230741 | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. |
No.888, Zhujiang Road, Juegang Street, Rudong County (Life | Nantong | 226499 | |
| K062096 | KOREAMEDICO CO. LTD. |
2F, 839-9 HWAGOK-4-DONG, | SEOUL | 157-902 | |
| K103574 | Lehnus & Associates Consulting |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301-8804 |
| K171136 | LIA Diagnostics |
1015 Chestnut St | Philadelphia | PA | 19107 |
| K060825 | MIZUHO USA, INC. |
12131 COMMUNITY RD. | POWAY | CA | 92064 |
| K964002 | MIZUHO USA, INC. |
6730 MESA RIDGE RD., SUITE D | SAN DIEGO | CA | 92121 |
| K043231 | MIZUHO USA, INC. |
12131 COMMUNITY RD. | POWAY | CA | 92064 |
| K242135 | Nanjing Synthgene Medical Technology Co., Ltd. |
Building B6-2, No. 9, Weidi Road, Xianlin University Town | Nanjing | 210000 | |
| K232864 | Nantong Egens Biotechnology Co.,Ltd. |
No 1692 Xinghu Avenue Nantong Economy&Technology Development | Nantong | 226010 | |
| K123050 | NANTONG BIOTECHNOLOGY CO., LTD. |
12828 DOE LANE | GAITHERSBURG | MD | 20878 |
| K051963 | NATUREPLEX, LLC |
3791 AIRPARK ST. | MEMPHIS | TN | 38118 |
| K993141 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K973570 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K972682 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K962219 | PHAMATECH |
9265 ACTIVITY RD. | SANDIEGO | CA | 92126 |
| K980532 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K122907 | POLYMED THERAPEUTICS, INC |
27001 LA PAZ ROAD, | MISSION VIEJO | CA | 92691 |
| K192123 | Qingdao Hightop Biotech Co., Ltd. |
No. 369 Hedong Road, Hi-tech Industrial Development Zone | Qingdao | 266112 | |
| K974821 | QUIDEL CORP. |
10165 MCKELLAR CT. | SAN DIEGO | CA | 92121 |
| K981722 | QUIDEL CORP. |
10165 MCKELLAR CT. | SAN DIEGO | CA | 92121 |
| K053236 | RUNBIO BIOTECH CO., LTD. |
2941 61ST. AVE NE | TACOMA | WA | 98422 |
| K172627 | Runbio BioTech Co.,Ltd |
Rongsheng Technology Garden, Shantou University Road | Shantou | 515063 | |
| K181551 | Runbio BioTech Co.,Ltd |
Rongsheng Technological Zone, University Road | Shantou | 515063 | |
| K974154 | SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL | SAN ANTONIO | TX | 78240 |
| K991193 | SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL | SAN ANTONIO | TX | 78240 |
| K974021 | SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL | SAN ANTONIO | TX | 78240 |
| K200133 | Safecare Biotech (Hangzhou) Co., Ltd. |
18 Haishu Road, Yuhang District | Hangzhou | ||
| K962721 | SALIVA DIAGNOSTIC SYSTEMS |
15 OAK STREET, SUITE 3 | BEVERLY FARMS | MA | 01915 |
| K002049 | SELFCARE, INC. |
200 PROSPECT ST. | WALTHAM | MA | 02154-3457 |
| K960436 | SELFCARE, INC. |
MERVUE INDUSTRIAL ESTATE | GALWAY | ||
| K110433 | SPD DEVELOPMENT COMPANY LIMITED |
STANNARD WAY | BEDFORD, BEDFORDSHIRE | MK44 3UP | |
| K213379 | SPD Swiss Precision Diagnostics GmbH |
47 Route de Saint Georges, Petit-Lancy | Geneva | CH-1213 | |
| K240025 | SPD Swiss Precision Diagnostics GmbH |
Route de St Georges, 47 | Geneva | 1213 | |
| K200913 | SPD Swiss Precision Diagnostics GmbH |
47 Route de St Georges, Petit-Lancey | Geneva | ch-1213 | |
| K210341 | SPD Swiss Precision Diagnostics GmbH |
47 Route de Saint Georges, Petit-Lancy | Geneva | CH-1213 | |
| K031798 | STANDARD DIAGNOSTICS, INC. |
30 NORTHPORT ROAD | SOUND BEACH | NY | 11789-1734 |
| K142754 | Sugentech, Inc. |
Daejeon Bioventure Town, 1662, Yuseong-daero, Yuseong-gu | Daejeon | 305-811 | |
| K963341 | SYNTRON BIORESEARCH, INC. |
2774 LOKER AVE. WEST | CARLSBAD | CA | 92008 |
| K960117 | SYNTRON BIORESEARCH, INC. |
2774 LOKER AVE. WEST | CARLSBAD | CA | 92008 |
| K103487 | TaiDoc Technology Corporation |
3F,5F, NO.127 WUGONG 2ND RD, | TAIPEI COUNTY | 24888 | |
| K973208 | TEXAS IMMUNOLOGY, INC. |
5400 SPUR 248 | TYLER | TX | 75707 |
| K112449 | Tianjin New Bay Bioresearch Co., Ltd. |
5230 VIA PRIMARIA | YORBA LINDA | CA | 92886 |
| K182328 | True Diagnostics, Inc. |
2782 Loker Ave West | Carlsbad | CA | 92010 |
| K081150 | TURKLAB MEDICAL DEVICES INC |
10040 SK. ATATURK ORGANIZE | IZMIR, | 35100 | |
| K131236 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
| K960316 | UNIPATH LTD. |
NORSE ROAD | BEDFORD MK41 OQG | ||
| K030659 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K060128 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K040341 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K013372 | UNIPATH LTD. |
390 PARK AVE. | NEW YORK | NY | 10022-4698 |
| K023699 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K041404 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K990262 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K993333 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K061769 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K050930 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K033658 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K032939 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K042280 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K040329 | UNIPATH LTD. |
PRIORY BUSINESS PARK | BEDFORD | MK44 3UP | |
| K960733 | VANGUARD BIOMEDICAL CORP. |
10225 BARNES CANYON RD., | SAN DIEGO | CA | 92121 |
| K041273 | W.H.P.M., INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K183097 | Weihai Kangzhou Biotechnology Engineering Co., Ltd |
Room401, Building B, Innovation Entrepreneurship Base, | Weihai City | 264200 | |
| K190705 | Wholepower Biotech Co., Ltd. |
Unit 4, Dongjun Palza, Dongfengdong Road | Guangzhou | 510008 | |
| K990576 | WYNTEK DIAGNOSTICS, INC. |
6146 NANCY RIDGE DR., | SAN DIEGO | CA | 92121 |
| K965184 | WYNTEK DIAGNOSTICS, INC. |
6146 NANCY RIDGE DR., | SAN DIEGO | CA | 92121 |
| K023027 | YD DIAGNOSTICS |
962 ALLEGRO LN. | APOLLO BEACH | FL | 33572 |
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