THYRO TEST
FDA 510(k) clearance K030912 · decided 2003-07-25
Clearance details
- K-number
- K030912
- Device name
- THYRO TEST
- Applicant
- Thryotec
- Decision
- Substantially Equivalent
- Date received
- 2003-03-24
- Decision date
- 2003-07-25
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- JLW
- Device class
- 2
- Regulation number
- 862.1690
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thyrotest TSH POC Rapid membrane test. In vitro diagnostic. recall (Z-0646-2007) | ThyroTec Inc | 2007-03-22 |