ROCHE REAGENT FOR BUN— 510(k) K954000
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K954000 for ROCHE REAGENT FOR BUN, Substantially Equivalent on 1995-10-25. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code CDQ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Recent devices under product code CDQ
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