DRX HBA1C - FOR PRESCRIPTION HOME USE— 510(k) K000885
Substantially EquivalentMetrika, Inc.
FDA 510(k) clearance K000885 for DRX HBA1C - FOR PRESCRIPTION HOME USE, Substantially Equivalent on 2000-09-26. Applicant: Metrika, Inc.. Device class: 2.
Clearance details
- Applicant
- Metrika, 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
- Sunnyvale, CA, US
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