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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 K850052
Device Name ANAEROBE KIT
Applicant
Austin Biological Laboratories
6620-A Manor Rd.
Austin,  TX  78723
Applicant Contact RAY SCHNEIDER
Correspondent
Austin Biological Laboratories
6620-A Manor Rd.
Austin,  TX  78723
Correspondent Contact RAY SCHNEIDER
Regulation Number866.2660
Classification Product Code
JSP  
Date Received01/08/1985
Decision Date 03/05/1985
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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