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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 K894848
Device Name HAEMOPHILUS TEST MEDIUM (BROTH)
Applicant
Regional Media Laboratories
12076 Santa Fe Dr.
P.O. Box 14428
Lenexa,  KS  66215
Applicant Contact BRENDA TEPLY
Correspondent
Regional Media Laboratories
12076 Santa Fe Dr.
P.O. Box 14428
Lenexa,  KS  66215
Correspondent Contact BRENDA TEPLY
Regulation Number866.1700
Classification Product Code
JSO  
Date Received07/31/1989
Decision Date 09/06/1989
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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