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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, non-propagating transport
510(k) Number K965152
Device Name A.C.T. II
Applicant
REMEL CO.
12076 SANTA FE DR.
LENEXA,  KS  66215
Applicant Contact MARY ANN SILVIUS
Correspondent
REMEL CO.
12076 SANTA FE DR.
LENEXA,  KS  66215
Correspondent Contact MARY ANN SILVIUS
Regulation Number866.2390
Classification Product Code
JSM  
Date Received12/23/1996
Decision Date 01/22/1997
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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