FLEXLAB 3.6, ACCELERATOR A3600
FDA 510(k) clearance K121012 · decided 2012-08-31
Clearance details
- K-number
- K121012
- Device name
- FLEXLAB 3.6, ACCELERATOR A3600
- Applicant
- Inpeco S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2012-04-03
- Decision date
- 2012-08-31
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- CEM
- Device class
- 2
- Regulation number
- 862.1600
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Segrate, Milan, IT
- Third-party review
- No
- Expedited review
- No
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