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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K871445
Device Name CONTROLCHEK(TM)
Applicant
Petra Biomedical Products, Inc.
4111 S. Darlington, Suite 200
Tulsa,  OK  74135
Applicant Contact MICHAEL D ROARK
Correspondent
Petra Biomedical Products, Inc.
4111 S. Darlington, Suite 200
Tulsa,  OK  74135
Correspondent Contact MICHAEL D ROARK
Regulation Number866.2660
Classification Product Code
JTO  
Date Received04/13/1987
Decision Date 04/29/1987
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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