LIQUI-HEME GLYCO A1C ASSAY— 510(k) K031296
Substantially EquivalentBiodiagnostic Intl
FDA 510(k) clearance K031296 for LIQUI-HEME GLYCO A1C ASSAY, Substantially Equivalent on 2004-10-15. Applicant: Biodiagnostic Intl. Device class: 2.
Clearance details
- Applicant
- Biodiagnostic Intl
- 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
- Brea, CA, US
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