Atlas FDA

CFM

21 FDA 510(k) clearances · Product code

35 daysmedian time to decision
69 days90th percentile
21clearances measured

FDA profile

Official device name
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Device class
Class I (low risk)
Regulation
21 CFR 862.1410
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2007: 9 · 2008: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (K984119)Wako Chemicals USA, Inc.1999-01-15
IRON (K981581)Abbott Laboratories1998-06-08
UIBC FOR DISCREET RANDOM ACCESS ANALYZER (K932871)Catachem, Inc.1993-09-08
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (K913705)Em Diagnostic Systems, Inc.1991-10-09
SYNERMED SERUM IRON-600 REAGENT KIT (K912912)Synermed, Inc.1991-07-30
SYNERMED SERUM IRON REAGENT KIT (K902918)Synermed, Inc.1990-07-31
CLINISTAT POTASSIUM REAGENT TEST (K895047)Heraeus Kulzer, Inc.1989-10-17
IRON REAGENT (K891155)Medical Analysis Systems, Inc.1989-04-18
ABBOTT A-GENT IRON REAGENT KIT (K873120)Abbott Laboratories1987-08-25
TOTAL IRON BINDING CAPACITY PROCEDURE (K861602)Data Medical Associates, Inc.1986-05-23
DART IRON & IRON BINDING CAPACITY REAGENT (K854305)Coulter Electronics, Inc.1985-11-12
DATA CHEM IRON PROCEDURE (K852583)Data Medical Associates, Inc.1985-07-12
SERUM IRON & SERUM IRON BINDING CAPACI (K842155)Diagnostic Chemicals, Ltd. (Usa)1984-08-07
TDX REA IRON DIAGNOSTIC KIT (K842505)Abbott Laboratories1984-08-07
SERUM IRON & SERUM IRON BINDING CAPACITY (K842156)Diagnostic Chemicals, Ltd. (Usa)1984-08-07
TOTAL IRON UIBC/TIBC ASSAY (K840485)Somas Medical Industries, Inc.1984-03-12
DIRECT IRON REAGENT SET (K834396)Seragen Diagnostics, Inc.1984-02-21
FEB TEST (K830564)Wako Chemicals USA, Inc.1983-03-29
CORNING 902 SODIUM POTASSIUM ANALYZER (K820629)Corning Medical & Scientific1982-03-25
IRON KIT (K810085)Bio-Analytics Laboratories, Inc.1981-01-28
ELVI SERUM IRON (K792406)Volu Sol Medical Industries1979-12-07

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Every clearance here is in the API, with alerts when new ones post.