510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DJYClass I

Ion-Exchange Chromatography

21 CFR 862.2230 / Clinical Chemistry
FDA source (opens on fda.gov)

DJY is the FDA product code for Ion-Exchange Chromatography, a class I device type, regulated under 21 CFR 862.2230. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DJY
Device name
Ion-Exchange Chromatography
Regulation
21 CFR 862.2230
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
0

Clearances, product code DJY

By decision year
11 clearances under product code DJY with a decision year between 1980 and 1989, 1983 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code DJY by decision year
YearClearances
19801
19835
19841
19851
19882
19891

Applicants with the most clearances

Product code DJY
Applicants holding the most 510(k) clearances under product code DJY
ApplicantClearances
E.I. Dupont de Nemours & Co., Inc.4
Supelco, Inc.2
Analytichem International, Inc.1
Berwick Medical Products, Inc.1
Cardiovascular Devices, Inc.1
Hamilton Co1
Lkb Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code