Cleared Traditional

SYNTHETIC VDRL ANTIGEN

K993633 · Centers For Disease Control and Prevention · Microbiology
Feb 2000
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K993633 is an FDA 510(k) clearance for the SYNTHETIC VDRL ANTIGEN, a Antigens, Nontreponemal, All (Class II — Special Controls, product code GMQ), submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on February 23, 2000, 119 days after receiving the submission on October 27, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number K993633 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1999
Decision Date February 23, 2000
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GMQ — Antigens, Nontreponemal, All
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3820

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