FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K181334 | Biokit, S.A. |
Can Male, S/N | Llica d'Amunt | 08186 | |
| K081687 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K061239 | EUROIMMUN US LLC |
429 ROCKAWAY VALLEY ROAD | BOONTON TOWNSHIP | NJ | 07005 |
| K993724 | MRL DIAGNOSTICS |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K181514 | Quest International, Inc. |
1935 SW Martin Highway | Palm City | FL | 34990 |
| K152353 | Quest International, Inc. |
8127 NW 29th Street | Miami | FL | 33122 |
| K220924 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K033106 | TRINITY BIOTECH USA |
2823 GIRTS RD. | JAMESTOWN | NY | 14701 |
| K103603 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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