S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023— 510(k) K091711
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearance K091711 for S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023, Substantially Equivalent on 2009-12-11. Applicant: Alfa Wassermann Diagnostic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, 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
- West Caldwell, NJ, US
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