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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGONODECTEN
Generic NameTEST REAGENTS, NEISSERIA GONORRHOEAE BIOCHEMICAL
Regulation Number866.2660
ApplicantMediserve International, Inc.
Granger, Indiana 
PMA NumberP770010
Supplement NumberS002
Date Received10/14/1981
Decision Date11/19/1981
Product Code LTS 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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