ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI— 510(k) K926441
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K926441 for ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI, Substantially Equivalent on 1993-05-26. 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
- Branchburg, NJ, US
Recent devices under product code KLT
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