Multichem A1c
FDA 510(k) clearance K162514 · decided 2016-10-26
Clearance details
- K-number
- K162514
- Device name
- Multichem A1c
- Applicant
- Technopath Manufacturing
- Decision
- Substantially Equivalent
- Date received
- 2016-09-08
- Decision date
- 2016-10-26
- Days to decision
- 48 days
- Clearance type
- Abbreviated
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ballina, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.