Atlas FDA

DJY

11 FDA 510(k) clearances · Product code

43 daysmedian time to decision
132 days90th percentile
11clearances measured

FDA profile

Official device name
Ion-Exchange Chromatography
Device class
Class I (low risk)
Regulation
21 CFR 862.2230
Medical specialty
Clinical Chemistry
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
THE CDI(R) SYSTEM 400 (K890113)Cardiovascular Devices, Inc.1989-05-23
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (K883615)Supelco, Inc.1988-12-16
SOLID PHASE EXTRACTION TUBES (K881361)Supelco, Inc.1988-08-08
DUPONT PREP TYPE SI EXTRACITON CARTRIDGE (K850963)E.I. Dupont DE Nemours & Co., Inc.1985-03-25
TRISACRYL GF 05 & TRISACRYL GF 2000 (K840985)Lkb Instruments, Inc.1984-04-19
HC40/HC75 PREPACKED COLUMS (K832198)Hamilton Co.1983-08-12
PREFILLED IEC COLUMNS (K831289)Berwick Medical Products, Inc.1983-06-16
DUPONT PREP TYPE AS EXTRACTION CARTRIDE (K830693)E.I. Dupont DE Nemours & Co., Inc.1983-04-05
DUPONT PREP OD EXTRACTION CARTRIDE (K830692)E.I. Dupont DE Nemours & Co., Inc.1983-04-05
PREP TYPE A EXTRACTION CARTRIDGE (K823697)E.I. Dupont DE Nemours & Co., Inc.1983-01-05
BOND ELUT COLUMNS (K800061)Analytichem International, Inc.1980-03-12

Track DJY automatically

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