Cleared Traditional

ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)

K030528 · Clinical Data · Chemistry

Jun 2003

Decision

118d

Days

Class 1

Risk

About This 510(k) Submission

K030528 is an FDA 510(k) clearance for the ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL), a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Clinical Data (Brea, US). The FDA issued a Cleared decision on June 17, 2003, 118 days after receiving the submission on February 19, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number	K030528 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2003
Decision Date	June 17, 2003
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF