Panels › Microbiology › Product code GTH · Class 2
Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
Regulation 866.3390
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GTH
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 1 | 0 |
| Clinical Sciences, Inc. | 1 | 0 |
| Syva Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 1990 | K900546 | BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT Baxter Healthcare Corp | GTH |
| May 29, 1986 | K861835 | MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST Syva Co. | GTH |
| Mar 3, 1980 | K800328 | NEISSERIA GONORRHOEAE FLUORO-KIT Clinical Sciences, Inc. | GTH |
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