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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test Reagents, Neisseria Gonorrhoeae Biochemical
510(k) Number K954784
Device Name DRYSIDE NEISSERIA
Applicant
Difco Laboratories, Inc.
17197 N. Laurel Park
Suite 400
Livouia,  MI  48152
Applicant Contact DAVID W GATES
Correspondent
Difco Laboratories, Inc.
17197 N. Laurel Park
Suite 400
Livouia,  MI  48152
Correspondent Contact DAVID W GATES
Regulation Number866.2660
Classification Product Code
LTS  
Date Received10/17/1995
Decision Date 01/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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