ROCHE STANDARDS FOR THE COBAS ISE MODULE— 510(k) K897071
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K897071 for ROCHE STANDARDS FOR THE COBAS ISE MODULE, Substantially Equivalent on 1990-03-09. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montclair, NJ, US
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