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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name culture media, antimicrobial susceptibility test, excluding mueller hinton agar
510(k) Number K964560
Device Name BHI W/VANCOMYCIN AGAR
Applicant
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA,  CA  93455
Applicant Contact MELISSA M TRAYLOR
Correspondent
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA,  CA  93455
Correspondent Contact MELISSA M TRAYLOR
Regulation Number866.1700
Classification Product Code
JSO  
Date Received11/13/1996
Decision Date 01/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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