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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, Escherichia Coli
510(k) Number K874288
Device Name PHADEBACT ETEC-LT TEST
Applicant
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Applicant Contact ALBERT P MAYO
Correspondent
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Correspondent Contact ALBERT P MAYO
Regulation Number866.3255
Classification Product Code
GNA  
Date Received10/20/1987
Decision Date 09/02/1988
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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