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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K896566
Device Name MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
Applicant
Medical Specialties, Inc.
2470 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact JERRY L COTTON
Correspondent
Medical Specialties, Inc.
2470 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact JERRY L COTTON
Regulation Number866.1640
Classification Product Code
JWY  
Date Received11/20/1989
Decision Date 02/09/1990
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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