K033864 is an FDA 510(k) clearance for the GENZYME OSOM TRICHOMONAS RAPID TEST. This device is classified as a Kit, Screening, Trichomonas (Class I - General Controls, product code JWZ).
Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on April 2, 2004, 112 days after receiving the submission on December 12, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K033864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2003 |
| Decision Date | April 02, 2004 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JWZ — Kit, Screening, Trichomonas |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |