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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 K881380
Device Name B. FRAGTEX
Applicant
American Biomedical Products, Inc.
P.O. Box 690355
Tulsa,  OK  74169
Applicant Contact JAMES F MAHER
Correspondent
American Biomedical Products, Inc.
P.O. Box 690355
Tulsa,  OK  74169
Correspondent Contact JAMES F MAHER
Regulation Number866.2660
Classification Product Code
JSP  
Date Received04/01/1988
Decision Date 10/06/1988
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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