Cleared Traditional

RANDOX ALBUMIN

K000483 · Randox Laboratories, Ltd. · Chemistry
Mar 2000
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K000483 is an FDA 510(k) clearance for the RANDOX ALBUMIN, a Bromcresol Purple Dye-binding, Albumin (Class II — Special Controls, product code CJW), submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on March 31, 2000, 46 days after receiving the submission on February 14, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K000483 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2000
Decision Date March 31, 2000
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJW — Bromcresol Purple Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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