ROCHE(R) CARDIOSCREEN-CK— 510(k) K891462

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K891462 for ROCHE(R) CARDIOSCREEN-CK, Substantially Equivalent on 1989-05-22. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 1989-03-15
Decision date: 1989-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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