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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, Mueller Hinton Agar/Broth
510(k) Number K850291
Device Name MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
Applicant
REMEL CO.
12076 SANTA FE DR.
LENEXA,  KS  66215
Applicant Contact JAMES G BAXENDALE
Correspondent
REMEL CO.
12076 SANTA FE DR.
LENEXA,  KS  66215
Correspondent Contact JAMES G BAXENDALE
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received01/24/1985
Decision Date 05/10/1985
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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