Cleared Traditional

WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002

K013102 · Wiener Laboratories Saic · Chemistry
Nov 2001
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K013102 is an FDA 510(k) clearance for the WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002, a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on November 13, 2001, 57 days after receiving the submission on September 17, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K013102 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2001
Decision Date November 13, 2001
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JMO — Ferrozine (colorimetric) Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415

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