COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR— 510(k) K852320
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K852320 for COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR, Substantially Equivalent on 1985-07-09. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LAR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nutley, NJ, US
Recent devices under product code LAR
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