K861835 is an FDA 510(k) clearance for the MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST. This device is classified as a Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae (Class II - Special Controls, product code GTH).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on May 29, 1986, 16 days after receiving the submission on May 13, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K861835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1986 |
| Decision Date | May 29, 1986 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTH — Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |