FDA 510(k) Applications for Medical Device:
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K120959 | Bio-Rad Laboratories |
BIOPLEX 2200 DIVISION | BENICIA | CA | 94510 |
| K090409 | Bio-Rad Laboratories |
6565 185TH AVE, NE | REDMOND | WA | 98052 |
| K181333 | Biokit, S.A. |
Can Male S/N | Llica dÆAmunt | 08186 | |
| K213987 | Biokit, S.A. |
Av. Can Montcau, 7 | Llica dÆAmunt | 08186 | |
| K081685 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K062543 | FOCUS DIAGNOSTICS, INC. |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K071510 | FOCUS DIAGNOSTICS, INC. |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K071511 | FOCUS DIAGNOSTICS, INC. |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K021429 | FOCUS TECHNOLOGIES, INC. |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K021486 | FOCUS TECHNOLOGIES, INC. |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K131334 | GOLD STANDARD DIAGNOSTICS |
2851 SPAFFORD ST | DAVIS | CA | 95618 |
| K984343 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K993754 | MRL DIAGNOSTICS |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K162276 | QUEST INTERNATIONAL, INC |
8127 NW 29TH STREET | MIAMI | FL | 33122 |
| K220923 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K120625 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K143236 | THERANOS, INC. |
1701 PAGE MILL ROAD | PALO ALTO | CA | 94304 |
| K033105 | TRINITY BIOTECH USA |
2823 GIRTS RD. | JAMESTOWN | NY | 14701 |
| K072178 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K103363 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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