Cleared Traditional

FITC GOAT ANTI-HUMAN IGM H CHAIN

K832265 · Gelco Diagnostics, Inc. · Immunology
Oct 1983
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K832265 is an FDA 510(k) clearance for the FITC GOAT ANTI-HUMAN IGM H CHAIN, a Igm, Antigen, Antiserum, Control (Class II — Special Controls, product code DFT), submitted by Gelco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983, 123 days after receiving the submission on June 30, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K832265 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1983
Decision Date October 31, 1983
Days to Decision 123 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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