Cleared Traditional

IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR

K955797 · Randox Laboratories, Ltd. · Immunology
Apr 1996
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K955797 is an FDA 510(k) clearance for the IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR, a Igm, Antigen, Antiserum, Control (Class II — Special Controls, product code DFT), submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on April 5, 1996, 105 days after receiving the submission on December 22, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K955797 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1995
Decision Date April 05, 1996
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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