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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Neisseria Gonorrhoeae
510(k) Number K852582
Device Name GONI-KIT
Applicant
Culture Kits, Inc.
14 Prentice St.
P.O. Box 748
Norwich,  NY  13815
Applicant Contact STEPHANIE G PITZER
Correspondent
Culture Kits, Inc.
14 Prentice St.
P.O. Box 748
Norwich,  NY  13815
Correspondent Contact STEPHANIE G PITZER
Regulation Number866.2660
Classification Product Code
JSX  
Date Received06/18/1985
Decision Date 07/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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