Cleared Traditional

VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010

K851504 · Ncs Diagnostics, Inc. · Microbiology

Aug 1985

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K851504 is an FDA 510(k) clearance for the VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010, a Antisera, Control For Nontreponemal Tests (Class II — Special Controls, product code GMP), submitted by Ncs Diagnostics, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on August 19, 1985, 126 days after receiving the submission on April 15, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number	K851504 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1985
Decision Date	August 19, 1985
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—