Cleared Traditional

QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD

K901453 · Isolab, Inc. · Immunology
Apr 1990
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K901453 is an FDA 510(k) clearance for the QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD, a Igm, Antigen, Antiserum, Control (Class II — Special Controls, product code DFT), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on April 12, 1990, 16 days after receiving the submission on March 27, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K901453 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1990
Decision Date April 12, 1990
Days to Decision 16 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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