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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dna-reagents, neisseria
510(k) Number K070172
Device Name AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Applicant
ROCHE DIAGNOSTICS CORPORATION
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46256
Applicant Contact THERESA AMBROSE BUSH
Correspondent
ROCHE DIAGNOSTICS CORPORATION
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46256
Correspondent Contact THERESA AMBROSE BUSH
Regulation Number866.3390
Classification Product Code
LSL  
Date Received01/18/2007
Decision Date 04/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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