K875138 is an FDA 510(k) clearance for the TRICHOMATE(R) SUPER. This device is classified as a Kit, Screening, Trichomonas (Class I - General Controls, product code JWZ).
Submitted by Mercia Diagnostics , Ltd. (Guildford, Surrey England, GB). The FDA issued a Cleared decision on May 13, 1988, 150 days after receiving the submission on December 15, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K875138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1987 |
| Decision Date | May 13, 1988 |
| Days to Decision | 150 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 |