510(k) K974503— ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

Substantially Equivalent

Roche Molecular Systems, Inc.

Clearance details

Applicant: Roche Molecular Systems, Inc.
Product code: Code LSL
Advisory panel: Microbiology
Date received: 1997-11-28
Decision date: 1999-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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