COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS— 510(k) K852319
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K852319 for COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS, Substantially Equivalent on 1985-06-25. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LAN
- 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, NY, US
Recent devices under product code LAN
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