AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE— 510(k) K070172

Name: FDA 510(k) clearance K070172
Creator: U.S. Food and Drug Administration
Published: 2007-04-17

Substantially Equivalent

Roche Diagnostics Corporation

FDA 510(k) clearance K070172 for AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE, Substantially Equivalent on 2007-04-17. Applicant: Roche Diagnostics Corporation. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corporation
Product code: Code LSL
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 2007-01-18
Decision date: 2007-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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