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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Neisseria Gonorrhoeae
510(k) Number K881501
Device Name MODIFIED IDS RAPID NH SYSTEM
Applicant
Innovative Diagnostic Systems, Inc.
3404 Oakcliff Rd. #C-1
Atlanta,  GA  30340
Applicant Contact LOUIS A ERIQUEZ,PHD
Correspondent
Innovative Diagnostic Systems, Inc.
3404 Oakcliff Rd. #C-1
Atlanta,  GA  30340
Correspondent Contact LOUIS A ERIQUEZ,PHD
Regulation Number866.2660
Classification Product Code
JSX  
Date Received04/11/1988
Decision Date 05/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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