Cleared Traditional

QUANTIMETRIC PLUS IGM REAGENT KIT

K855010 · Kallestad Laboratories, Inc. · Immunology
Feb 1986
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K855010 is an FDA 510(k) clearance for the QUANTIMETRIC PLUS IGM REAGENT KIT, a Igm, Antigen, Antiserum, Control (Class II — Special Controls, product code DFT), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on February 28, 1986, 74 days after receiving the submission on December 16, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K855010 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1985
Decision Date February 28, 1986
Days to Decision 74 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DFT — Igm, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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