COBAS FP REAGENTS FOR CARBAMAZEPINE— 510(k) K850807
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K850807 for COBAS FP REAGENTS FOR CARBAMAZEPINE, Substantially Equivalent on 1985-03-22. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code KLT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Belleville, NJ, US
Recent devices under product code KLT
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