COBAS EIA(TM) PHOTOMETER— 510(k) K881877
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K881877 for COBAS EIA(TM) PHOTOMETER, Substantially Equivalent on 1988-06-10. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JJQ
- Device class
- Class 1
- Regulation
- 21 CFR 862.2300
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montclair, NJ, US
Recent devices under product code JJQ
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