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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 K854150
Device Name PHADIRECT STREP A TEST
Applicant
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854 -3911
Applicant Contact BRIAN D BOLLWAGE
Correspondent
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854 -3911
Correspondent Contact BRIAN D BOLLWAGE
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received10/11/1985
Decision Date 10/23/1985
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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