Cleared Traditional

RANDOX MICROALBUMIN

K002674 · Randox Laboratories, Ltd. · Chemistry
Oct 2000
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K002674 is an FDA 510(k) clearance for the RANDOX MICROALBUMIN, a Albumin, Fitc, Antigen, Antiserum, Control (Class II — Special Controls, product code DDZ), submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on October 5, 2000, 38 days after receiving the submission on August 28, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K002674 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2000
Decision Date October 05, 2000
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DDZ — Albumin, Fitc, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040