ROCHE OXI/FERM II— 510(k) K923313

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K923313 for ROCHE OXI/FERM II, Substantially Equivalent on 1993-04-05. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LQM
Advisory panel: Microbiology
Date received: 1992-07-07
Decision date: 1993-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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