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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 Types, H. Influenza
510(k) Number K884967
Device Name BACTIGEN(R) H. INFLUENZAE TYPE B
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 Number866.3300
Classification Product Code
GRP  
Date Received11/30/1988
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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