TRICHOMATE(R) SUPER
FDA 510(k) clearance K875138 · decided 1988-05-13
Clearance details
- K-number
- K875138
- Device name
- TRICHOMATE(R) SUPER
- Applicant
- Mercia Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-15
- Decision date
- 1988-05-13
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- JWZ
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Guildford, Surrey England, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.