HEMOGLOBIN A1C REAGENT SET
FDA 510(k) clearance K031539 · decided 2003-08-06
Clearance details
- K-number
- K031539
- Device name
- HEMOGLOBIN A1C REAGENT SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2003-05-16
- Decision date
- 2003-08-06
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lincoln Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.