CAPTIA(R) SYPHILIS M, MODIFICATION
FDA 510(k) clearance K904524 · decided 1990-12-26
Clearance details
- K-number
- K904524
- Device name
- CAPTIA(R) SYPHILIS M, MODIFICATION
- Applicant
- Mercia Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-27
- Decision date
- 1990-12-26
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LIP
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Guildford, Surrey England, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test K recall (Z-0819-2015) | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | 2014-12-16 |