FDA 510(k) Applications for Medical Device:
Reagent, Occult Blood
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K972763 | AERSCHER DIAGNOSTICS |
353 HIGH ST. | CHESTERTOWN | MD | 21620 |
| K981661 | AERSCHER DIAGNOSTICS |
353 HIGH ST. | CHESTERTOWN | MD | 21620 |
| K031356 | AERSCHER DIAGNOSTICS |
353 HIGH ST. | CHESTERTOWN | MD | 21620 |
| K070660 | ALFA SCIENTIFIC DESIGNS, INC. |
13200 GREGG ST. | POWAY | CA | 92064 |
| K021423 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K173212 | Alfa Scientific Designs, Inc. |
13200 Gregg St | Poway | CA | 92064 |
| K071242 | AMERITEK USA, INC. |
125 130TH ST. SE | EVERETT | WA | 98208 |
| K984269 | AMERITEK, INC. |
7030 35TH AVE., N.E. | SEATTLE | WA | 98115 |
| K080812 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K052598 | CARE DIAGNOSTIC, INC. |
1741 WIARD STREET | KLAMATH FALLS | OR | 97603 |
| K030216 | CARE PRODUCTS, INC. |
231 BANK STREET | WATERBURY | CT | 06702 |
| K002756 | DIAGNOSTICA, INC. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K143325 | EIKEN CHEMICAL CO. LTD |
4-19-9 TAITO | TAITO-KU | 110-8408 | |
| K002457 | ENTERIX INC. |
348 US ROUTE ONE | FALMOUTH, | ME | 04105 |
| K060930 | ENTERIX INC. |
236 FERNWOOD AVE. | EDISON | NJ | 08837 |
| K170548 | Enterix Inc. |
236 Fernwood Avenue | Edison | NJ | 08837 |
| K051806 | EPITOPE DIAGNOSTICS, INC. |
7955 DUNBROOK RD., SUITE B | SAN DIEGO | CA | 92126 |
| K162333 | GUANGZHOU WONDFO BIOTECH CO., LTD. |
WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY | GUANGZHOU | 510641 | |
| K003359 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K980671 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K992759 | IMMUNOSTICS, INC. |
3505 SUNSET AVE. | OCEAN | NJ | 07712 |
| K102664 | IMMUNOSTICS, INC. |
3505 SUNSET AVE. | OCEAN | NJ | 07712 |
| K060463 | IMMUNOSTICS, INC. |
3505 SUNSET AVE. | OCEAN | NJ | 07712 |
| K163554 | Immunostics, Inc. |
1750 Brielle Ave., AS | Ocean | NJ | 07712 |
| K171484 | Immunostics, Inc. |
1750 Brielle Ave. | Ocean | NJ | 07712 |
| K100031 | IND DIAGNOSTIC INC. |
1629 FOSTERS WAY | DELTA, BC | V3M 6S7 | |
| K113506 | IND DIAGNOSTICS INC. |
1629 FOSTERS WAY | DELTA, BRITISH COLUMBIA | V3M 6S7 | |
| K063673 | INNOVACON, INC. |
4106 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K002930 | MEDTEK DIAGNOSTICS, LLC. |
PO BOX 14125 | RESEARCH TRIANGLE PARK | NC | 27709-4125 |
| K022755 | MEDTEK LLC. |
10315B CHAPEL HILL RD. | MORRISVILLE | NC | 27560 |
| K063693 | NEW BAY BIORESEARCH CO. LTD. |
3108 AVENIDA OLMEDA | CARLSBAD | CA | 92009 |
| K110309 | ORIENT GENE BIOTECH |
150 CHERRY LANE RD | EAST STROUDSBURG | PA | 18301 |
| K041297 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K100817 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K033548 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K121397 | SEKISUI DIAGNOSTICS, LLC |
6659 Top Gun St | SAN DIEGO | CA | 92121 |
| K961062 | SMITHKLINE DIAGNOSTICS, INC. |
606 ELMWOOD AVE. | SHARON HILL | PA | 19079-1031 |
| K061065 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K073431 | Tianjin New Bay Bioresearch Co., Ltd. |
3108 AVENIDA OLMEDA | CARLSBAD | CA | 92009 |
| K041202 | W.H.P.M., INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K060953 | YD DIAGNOSTICS CORP. |
4304 EVERGREEN LANE | ANNANDALE | VA | 22003 |
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