MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C— 510(k) K003120
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K003120 for MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C, Substantially Equivalent on 2000-12-18. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- 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
- Indianapolis, IN, US
Recent devices under product code LCP
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