Atlas FDA

JQE

6 FDA 510(k) clearances · Product code

73 daysmedian time to decision
194 days90th percentile
6clearances measured

FDA profile

Official device name
Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Device class
Class I (low risk)
Regulation
21 CFR 862.1415
Medical specialty
Clinical Chemistry
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RecordFirmDate
CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM (K970248)Canyon Diagnostics, Inc.1997-02-11
KODAK EKTACHEM DT SLIDES (FE) (K934358)Eastman Kodak Company1994-03-21
J&S PEDIATRIC IRON SATURATING REAGENT (K910672)J.S. Medical Assoc.1991-04-29
TOTAL IRON BINDING CAPACITY TEST (K884649)Sclavo, Inc.1988-12-14
ALFERR TIBC TUBE (K864548)Benchmark Reagents1987-02-02
TIBC PRETREATMENT KIT (K842019)E.I. Dupont DE Nemours & Co., Inc.1984-06-22

Track JQE automatically

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