TQ HBA1C GEN3
FDA 510(k) clearance K102914 · decided 2011-01-20
Clearance details
- K-number
- K102914
- Device name
- TQ HBA1C GEN3
- Applicant
- Roche
- Decision
- Substantially Equivalent
- Date received
- 2010-10-01
- Decision date
- 2011-01-20
- Days to decision
- 111 days
- Clearance type
- Special
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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