Cleared Traditional

KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT

K854483 · Kallestad Laboratories, Inc. · Immunology
Dec 1985
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K854483 is an FDA 510(k) clearance for the KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT, a Reagent, Immunoassay, Igg (Class I — General Controls, product code KTO), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on December 11, 1985, 34 days after receiving the submission on November 7, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5530.

Submission Details

510(k) Number K854483 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1985
Decision Date December 11, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code KTO — Reagent, Immunoassay, Igg
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5530