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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Control For Nontreponemal Tests
510(k) Number K851504
Device Name VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
Applicant
Ncs Diagnostics, Inc.
3069 Universal Dr.
Mississauga, Ontario,  CA L4X2E2
Applicant Contact ED RAYNER
Correspondent
Ncs Diagnostics, Inc.
3069 Universal Dr.
Mississauga, Ontario,  CA L4X2E2
Correspondent Contact ED RAYNER
Regulation Number866.3820
Classification Product Code
GMP  
Date Received04/15/1985
Decision Date 08/19/1985
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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