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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 K092407
Device Name REMEL SPECTRA MRSA
Applicant
REMEL, INC.
12076 SANTA FE DR.
LENEXA,  KS  66215
Applicant Contact MARY ANN SILVIUS
Correspondent
REMEL, INC.
12076 SANTA FE DR.
LENEXA,  KS  66215
Correspondent Contact MARY ANN SILVIUS
Regulation Number866.1700
Classification Product Code
JSO  
Date Received08/06/2009
Decision Date 10/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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