Cleared Traditional

FTA-ABS TEST

K801959 · Immuno-Diagnostic Products, Inc. · Microbiology
Oct 1980
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K801959 is an FDA 510(k) clearance for the FTA-ABS TEST, a Antigen, Treponema Pallidum For Fta-abs Test (Class II — Special Controls, product code JWL), submitted by Immuno-Diagnostic Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980, 65 days after receiving the submission on August 19, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K801959 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1980
Decision Date October 23, 1980
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
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