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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceFLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
Generic NameGONOCOCCAL ANTIBODY TESTS
Regulation Number866.3290
ApplicantFisher Scientific Co., LLC
526 Route 303
Orangeburg, NY 10962
PMA NumberP770001
Date Received05/20/1977
Decision Date07/18/1979
Product Code LGB 
Notice Date 06/13/1980
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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