CAPTIA MEASLES IGM
FDA 510(k) clearance K140455 · decided 2014-05-22
Clearance details
- K-number
- K140455
- Device name
- CAPTIA MEASLES IGM
- Applicant
- Trinity Biotech USA
- Decision
- Substantially Equivalent
- Date received
- 2014-02-24
- Decision date
- 2014-05-22
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PCL
- Device class
- 1
- Regulation number
- 866.3520
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Jamestown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determination recall (Z-2782-2016) | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | 2016-09-12 |