MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR— 510(k) K871680
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K871680 for MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR, Substantially Equivalent on 1987-06-08. 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, NJ, US
Recent devices under product code LAN
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