FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K963645 | ARMKEL, LLC. |
1306F BAILES LN. | FREDERICK | MD | 21701 |
| K983886 | DIAGNOLOGY LTD. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K950670 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K010878 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K981306 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K002262 | DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. | MIAMI | FL | 33127 |
| K983541 | GULL LABORATORIES, INC. |
1011 MURRAY HOLLADAY RD. | SALT LAKE CITY | UT | 84117 |
| K953839 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K984346 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K000238 | MRL DIAGNOSTICS |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K963282 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K033059 | TRINITY BIOTECH, INC. |
PO BOX 1059 | JAMESTOWN | NY | 14702 |
| K983656 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K992166 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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