Cleared Traditional

LAB-TEK FTA-ABS KIT

K801928 · Miles Laboratories, Inc. · Microbiology
Aug 1980
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K801928 is an FDA 510(k) clearance for the LAB-TEK FTA-ABS KIT, a Antigen, Treponema Pallidum For Fta-abs Test (Class II — Special Controls, product code JWL), submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980, 8 days after receiving the submission on August 12, 1980. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K801928 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1980
Decision Date August 20, 1980
Days to Decision 8 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