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

Colorimetry, Salicylate

21 CFR 862.3830 / Clinical Toxicology
FDA source (opens on fda.gov)

DKJ is the FDA product code for Colorimetry, Salicylate, a class II device type, regulated under 21 CFR 862.3830. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
DKJ
Device name
Colorimetry, Salicylate
Regulation
21 CFR 862.3830
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
29
Ingested recalls
6

Clearances, product code DKJ

By decision year
29 clearances under product code DKJ with a decision year between 1981 and 2010, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DKJ by decision year
YearClearances
19811
19821
19833
19844
19851
19861
19874
19881
19902
19952
19961
19971
19982
20011
20022
20041
20101

Applicants with the most clearances

Product code DKJ
Applicants holding the most 510(k) clearances under product code DKJ
ApplicantClearances
Sekisui Diagnostics P.E.I. Inc.3
Em Diagnostic Systems, Inc.3
Abbott Medical2
Siemens Healthcare Diagnostics Inc.2
Diagnostic Chemicals, Ltd. (USA)2
Advanced Biomedical Methods, Inc.1
American Dade1
Bayer Diagnostics Corp.1
Bio-Analytics Laboratories, Inc.1
Clin Tech Diagnostics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code