COBAS-FP TDM CALIBRATION VERIFICATION TEST SET— 510(k) K962165
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K962165 for COBAS-FP TDM CALIBRATION VERIFICATION TEST SET, Substantially Equivalent on 1996-06-26. Applicant: Roche Diagnostic Systems, Inc..
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code DIF
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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