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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
510(k) Number K851650
Device Name PHADEBACT MONOCLONAL GC OMNI TEST
Applicant
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854 -3911
Applicant Contact ALBERT P MAYO
Correspondent
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854 -3911
Correspondent Contact ALBERT P MAYO
Regulation Number866.3390
Classification Product Code
LIC  
Date Received04/22/1985
Decision Date 07/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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