K020226 is an FDA 510(k) clearance for the XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03. This device is classified as a Kit, Screening, Trichomonas (Class I - General Controls, product code JWZ).
Submitted by Hellen Professional Services (Northridge, US). The FDA issued a Cleared decision on August 22, 2002, 212 days after receiving the submission on January 22, 2002.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K020226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2002 |
| Decision Date | August 22, 2002 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JWZ — Kit, Screening, Trichomonas |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |