ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR— 510(k) K952282

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K952282 for ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR, Substantially Equivalent on 1995-09-15. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1995-05-16
Decision date: 1995-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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