FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Propoxyphene
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013100 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K040445 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K022915 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K030835 | AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K955675 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821-6208 |
| K122752 | BRANAN MEDICAL CORP. |
140 Technology Dr Ste 400 | IRVINE | CA | 92618 |
| K152495 | Guangzhou Wondfo Biotech Co., Ltd. |
Wondfo Scientech Park, South China Univ. of technology | Guangzhou | 510641 | |
| K023795 | Lin-Zhi International, Inc. |
2391 ZANKER RD., SUITE 340 | SAN JOSE | CA | 95131-1124 |
| K111363 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K020787 | MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. | BURLINGTON | NC | 27215 |
| K983700 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K043303 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K993981 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K011163 | SYVA CO., DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95135 |
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