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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.
 
DeviceGONOSTICON DRI-DOT
Generic NameKIT, IDENTIFICATION, NEISSERIA GONORRHOEAE
Regulation Number866.2660
ApplicantOrganon, Inc.
9440 Telstar Ave., Suite 7
El Monte, CA 91731
PMA NumberN17985
Supplement NumberS001
Date Received02/23/1981
Decision Date04/14/1981
Product Code JSX 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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