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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 K972359
Device Name REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
Applicant
Remel, L.P.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact MARY ANN SILVIUS
Correspondent
Remel, L.P.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact MARY ANN SILVIUS
Regulation Number866.1700
Classification Product Code
JSO  
Date Received06/25/1997
Decision Date 08/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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