VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010

Antisera, Control For Nontreponemal Tests

NCS DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Ncs Diagnostics, Inc. with the FDA for Vdrl Carbon Antigen Test S900500, S900250 & S90010.

Pre-market Notification Details

Device IDK851504
510k NumberK851504
Device Name:VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
ClassificationAntisera, Control For Nontreponemal Tests
Applicant NCS DIAGNOSTICS, INC. 3069 UNIVERSAL DR. Mississauga, Ontario,  CA L4x2e2
ContactEd Rayner
CorrespondentEd Rayner
NCS DIAGNOSTICS, INC. 3069 UNIVERSAL DR. Mississauga, Ontario,  CA L4x2e2
Product CodeGMP  
CFR Regulation Number866.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-15
Decision Date1985-08-19

NIH GUDID Devices

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