COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)— 510(k) K980996

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K980996 for COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF), Substantially Equivalent on 1998-06-05. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code KHS
Advisory panel: Clinical Chemistry
Date received: 1998-03-17
Decision date: 1998-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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