VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
FDA 510(k) clearance K062501 · decided 2006-09-29
Clearance details
- K-number
- K062501
- Device name
- VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
- Applicant
- Maine Standards Co.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-25
- Decision date
- 2006-09-29
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Windham, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.