ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE— 510(k) K051376
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K051376 for ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE, Substantially Equivalent on 2005-08-23. Applicant: Roche Diagnostics. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CHH
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