K900546 is an FDA 510(k) clearance for the BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT. This device is classified as a Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae (Class II - Special Controls, product code GTH).
Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on June 15, 1990, 130 days after receiving the submission on February 5, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K900546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1990 |
| Decision Date | June 15, 1990 |
| Days to Decision | 130 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 |