Cleared Traditional

POLYCHACO FIA-ABS TEST FOR SYPHILIS

K831296 · Parasitic Disease Consultants · Immunology
Jul 1983
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K831296 is an FDA 510(k) clearance for the POLYCHACO FIA-ABS TEST FOR SYPHILIS, a Antigen, Treponema Pallidum For Fta-abs Test (Class II — Special Controls, product code JWL), submitted by Parasitic Disease Consultants (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983, 97 days after receiving the submission on April 20, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K831296 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1983
Decision Date July 26, 1983
Days to Decision 97 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JWL — Antigen, Treponema Pallidum For Fta-abs Test
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830