COBAS READY STAT PROFILE REAGENT STRIP— 510(k) K896234

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K896234 for COBAS READY STAT PROFILE REAGENT STRIP, Substantially Equivalent on 1990-02-16. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant
Roche Diagnostic Systems, Inc.
Product code
Code CKA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montclair, NJ, US
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