VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
FDA 510(k) clearance K130860 · decided 2013-04-25
Clearance details
- K-number
- K130860
- Device name
- VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
- Applicant
- Bio-Rad Laboratories, Inc., Clinical Systems Divis
- Decision
- Substantially Equivalent
- Date received
- 2013-03-28
- Decision date
- 2013-04-25
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.