Cleared Traditional

RANDOX PREALBUMIN

K000661 · Randox Laboratories, Ltd. · Immunology
Apr 2000
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K000661 is an FDA 510(k) clearance for the RANDOX PREALBUMIN, a Prealbumin, Antigen, Antiserum, Control (Class I — General Controls, product code JZJ), submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on April 13, 2000, 45 days after receiving the submission on February 28, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number K000661 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2000
Decision Date April 13, 2000
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JZJ — Prealbumin, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5060

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