FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Barbiturate
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K012996 | ABBOTT LABORATORIES |
1920 HURD MS 1-8 | IRVING | TX | 75038 |
| K050593 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K012824 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K023946 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K010125 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K003647 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K042975 | AMEDITECH, INC. |
10340 CAMINO SANTA FE | SAN DIEGO | CA | 92121 |
| K041712 | AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH ROAD | COLUMBIA | MD | 21045 |
| K992451 | AMERICAN BIO MEDICA CORP. |
1001 G STREET, NW | WASHINGTON | DC | 20001 |
| K151211 | Assure Tech. Co., Ltd |
2nd. Floor, Building 1, No. 10, Xiyuansan Road, | Hangzhou | 310030 | |
| K990280 | BIONIKE, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K002337 | BRANAN MEDICAL CORPORATION |
10015 MUIRLANDS RD. SUITE E | IRVINE | CA | 92618 |
| K140215 | CO-INNOVATION BIOTECH CO., LTD. |
NO. 13 YANYUAN ROAD. TIANHE DISTRICT | GUANGZHOU, GUANGDONG | 510507 | |
| K000459 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K955928 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K960664 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K973047 | DRIAL CONSULTANTS, INC. |
1420 LOS ANGELES AVE. STE 201 | SIMI VALLEY | CA | 93065 |
| K000522 | DRUG DETECTION DEVICES, LTD. |
6820 MEADOWRIDGE COURT | ALPHARETTA | GA | 30005 |
| K963529 | EDITEK, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K140665 | GENPRIME, INC |
502 W. Riversude, Suite 101 | Spokane | WA | 99201 |
| K143535 | GUANGZHOU WONDFO BIOTECH CO., LTD. |
WONDFO SCIENTECH PARK, SOUTH | GUANGZHOU | 510641 | |
| K050024 | Guangzhou Wondfo Biotech Co., Ltd. |
8903 SPRUCE MILL DRIVE | YARDLEY | PA | 19087 |
| K150791 | HEALGEN SCIENTIFIC LLC |
5213 MAPLE STREET | BELLAIRE | TX | 77401 |
| K161714 | IMMUNALYSIS CORPORATION |
829 TOWNE CENTER DRIVE | POMONA | CA | 91767 |
| K032764 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K033885 | Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. | SUNNYVALE | CA | 94085-2917 |
| K033334 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K002331 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K010959 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K010561 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K982745 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K001976 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K062165 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K012133 | PAN PROBE BIOTECH, INC. |
8515 ARJONS DR., SUITE A | SAN DIEGO | CA | 92126 |
| K982152 | PHAMATECH |
9265 ACTIVITY RD., #112-113 | SAN DIEGO | CA | 92126 |
| K070009 | PHAMATECH INC. |
10151 BARNES CANYON RD | SAN DIEGO | CA | 92121 |
| K070098 | PHAMATECH INC. |
10151 BARNES CANYON RD | SAN DIEGO | CA | 92121 |
| K962669 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K991018 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. ROUTE 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K961010 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K991082 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. ROUTE 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K991084 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. ROUTE 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K991076 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. ROUTE 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K041143 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K092268 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K983698 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K982551 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-1760 |
| K043211 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K991440 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K020136 | SUN BIOMEDICAL LABORATORIES, INC. |
604 VPR CENTER | BLACKWOOD | NJ | 08012 |
| K014089 | SUN BIOMEDICAL LABORATORIES, INC. |
604 VPR CENTER | BLACKWOOD | NJ | 08012 |
| K980349 | SYNTRON BIORESEARCH, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K974712 | SYNTRON BIORESEARCH, INC. |
1420 LOS ANGELES AVE. | SIMI VALLEY | CA | 93065 |
| K010934 | SYVA CO., DADE BEHRING, INC. |
P.O. BOX 49013 | SAN JOSE | CA | 95135 |
| K110515 | UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 | SAN JOSE | CA | 95112 |
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