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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 K880511
Device Name XACT NEISSERIA
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
JSX  
Date Received02/09/1988
Decision Date 08/25/1988
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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