K892263 is an FDA 510(k) clearance for the MERIFLUOR(TM) -TRICHOMONAS. This device is classified as a Kit, Screening, Trichomonas (Class I - General Controls, product code JWZ).
Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 24, 1989, 50 days after receiving the submission on April 4, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K892263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1989 |
| Decision Date | May 24, 1989 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JWZ — Kit, Screening, Trichomonas |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |