Cleared Traditional

VITALAB IRON REAGENT

K033983 · Clinical Data, Inc. · Chemistry
May 2004
Decision
150d
Days
Class 1
Risk

About This 510(k) Submission

K033983 is an FDA 510(k) clearance for the VITALAB IRON REAGENT, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on May 21, 2004, 150 days after receiving the submission on December 23, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K033983 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2003
Decision Date May 21, 2004
Days to Decision 150 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIY — Photometric Method, Iron (non-heme)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1410

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