Cleared Traditional

IRON TEST

K935176 · Em Diagnostic Systems, Inc. · Chemistry
Dec 1993
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K935176 is an FDA 510(k) clearance for the IRON TEST, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 16, 1993, 50 days after receiving the submission on October 27, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K935176 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1993
Decision Date December 16, 1993
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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