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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Anaerobic Identification
510(k) Number K820483
Device Name IDA RAPID O2A SYSTEM
Applicant
Innovative Diagnostic Systems, Inc.
3404 Oakcliff Rd. #C-1
Atlanta,  GA  30340
Correspondent
Innovative Diagnostic Systems, Inc.
3404 Oakcliff Rd. #C-1
Atlanta,  GA  30340
Regulation Number866.2660
Classification Product Code
JSP  
Date Received02/22/1982
Decision Date 03/15/1982
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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