Afinion HbA1c Dx
FDA 510(k) clearance K180296 · decided 2018-05-07
Clearance details
- K-number
- K180296
- Device name
- Afinion HbA1c Dx
- Applicant
- Alere Technologies AS
- Decision
- Substantially Equivalent
- Date received
- 2018-02-02
- Decision date
- 2018-05-07
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- PDJ
- Device class
- 2
- Regulation number
- 862.1373
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Oslo, NO
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.