ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS— 510(k) K973718

Substantially Equivalent

Roche Molecular Systems, Inc.

FDA 510(k) clearance K973718 for ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS, Substantially Equivalent on 1998-12-15. Applicant: Roche Molecular Systems, Inc..

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code MKZ
Advisory panel: Microbiology
Date received: 1997-09-29
Decision date: 1998-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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