Cleared Traditional

WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003

K013097 · Wiener Laboratories Saic · Chemistry
Nov 2001
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K013097 is an FDA 510(k) clearance for the WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), 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 862.1410.

Submission Details

510(k) Number K013097 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 JIY — Photometric Method, Iron (non-heme)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1410

Similar Devices — JIY Photometric Method, Iron (non-heme)

All 66
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061793 · Dade Behring, Inc. · Aug 2006
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
K060264 · Dade Behring, Inc. · Mar 2006
SENTINEL IRON LIQUID
K051115 · Sentinel Ch. Srl · Aug 2005
VITALAB IRON REAGENT
K033983 · Clinical Data, Inc. · May 2004
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
K030528 · Clinical Data · Jun 2003
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816 · Diagnostic Chemicals , Ltd. · May 2002