GLYCA-DIRECT FRUCTOSAMINE— 510(k) K023654
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K023654 for GLYCA-DIRECT FRUCTOSAMINE, Substantially Equivalent on 2003-05-02. Applicant: Polymedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymedco, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.