COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT— 510(k) K853009

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K853009 for COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT, Substantially Equivalent on 1986-03-04. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JSS
Advisory panel: Microbiology
Date received: 1985-07-16
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belleville, NJ, US

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