GLYCA-DIRECT FRUCTOSAMINE
FDA 510(k) clearance K023654 · decided 2003-05-02
Clearance details
- K-number
- K023654
- Device name
- GLYCA-DIRECT FRUCTOSAMINE
- Applicant
- Polymedco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-30
- Decision date
- 2003-05-02
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Cortlandt Manor, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.