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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 K831654
Device Name RIM BETA LACTAMASE TEST
Original Applicant
AUSTIN BIOLOGICAL LABORATORIES
Regulation Number866.2660
Classification Product Code
JTO  
Date Received05/23/1983
Decision Date 06/22/1983
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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