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

Name: FDA 510(k) clearance K853009
Creator: U.S. Food and Drug Administration
Published: 1986-03-04

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.. Device class: 1.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JSS
Device class: Class 1
Regulation: 21 CFR 866.2660
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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