K871279 is an FDA 510(k) clearance for the MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT. This device is classified as a Kit, Screening, Trichomonas (Class I - General Controls, product code JWZ).
Submitted by California Integrated Diagnostics, Inc. (Berkeley, US). The FDA issued a Cleared decision on April 8, 1987, 8 days after receiving the submission on March 31, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K871279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1987 |
| Decision Date | April 08, 1987 |
| Days to Decision | 8 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 |