CONE-TROL HEMOGLOBIN A1C CONTROL SET
FDA 510(k) clearance K121534 · decided 2012-06-20
Clearance details
- K-number
- K121534
- Device name
- CONE-TROL HEMOGLOBIN A1C CONTROL SET
- Applicant
- Cone Bioproducts
- Decision
- Substantially Equivalent
- Date received
- 2012-05-24
- Decision date
- 2012-06-20
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Seguin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.