ROCHE CARDIOTROL-CK— 510(k) K930889
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K930889 for ROCHE CARDIOTROL-CK, Substantially Equivalent on 1993-07-06. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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