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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K885003
Device Name BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
Applicant
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Applicant Contact ANN MACLEARIE
Correspondent
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Correspondent Contact ANN MACLEARIE
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received12/01/1988
Decision Date 02/07/1989
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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