JWZ
11 FDA 510(k) clearances · Product code
55 daysmedian time to decision
212 days90th percentile
11clearances measured
FDA profile
- Official device name
- Kit, Screening, Trichomonas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GENZYME OSOM TRICHOMONAS RAPID TEST (K033864) | Genzyme Corp. | 2004-04-02 |
| XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 (K020595) | Xenotope Diagnostics, Inc. | 2003-02-20 |
| XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 (K020226) | Hellen Professional Services | 2002-08-22 |
| MERIVIEW TM TRICHOMONAS (K894246) | Meridian Diagnostics, Inc. | 1989-08-15 |
| SUPER DUO (K892802) | Mercia Diagnostics , Ltd. | 1989-06-13 |
| MERIFLUOR(TM) -TRICHOMONAS (K892263) | Meridian Diagnostics, Inc. | 1989-05-24 |
| TRICHOMATE(R) SUPER (K875138) | Mercia Diagnostics , Ltd. | 1988-05-13 |
| TRICHOMONAS DIRECT ENZYME IMMUNOASSAY (K874259) | California Integrated Diagnostics, Inc. | 1987-12-07 |
| MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT (K871279) | California Integrated Diagnostics, Inc. | 1987-04-08 |
| SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (K852665) | Syncor Intl. Corp. | 1985-08-13 |
| PEM-T (K830497) | Hedeco | 1983-04-05 |
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Every clearance here is in the API, with alerts when new ones post.