COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID— 510(k) K953224
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K953224 for COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID, Substantially Equivalent on 1995-10-30. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LEG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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