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

Tetraphenyl Borate, Colorimetry, Potassium

21 CFR 862.1600 / Clinical Chemistry
FDA source (opens on fda.gov)

CEJ is the FDA product code for Tetraphenyl Borate, Colorimetry, Potassium, a class II device type, regulated under 21 CFR 862.1600. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CEJ
Device name
Tetraphenyl Borate, Colorimetry, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
16
Ingested recalls
0

Clearances, product code CEJ

By decision year
16 clearances under product code CEJ with a decision year between 1981 and 2005, 1988 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code CEJ by decision year
YearClearances
19812
19821
19831
19852
19862
19884
19902
19941
20051

Applicants with the most clearances

Product code CEJ
Applicants holding the most 510(k) clearances under product code CEJ
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic2
Technicon Instruments Corp.2
Bioclinical Systems, Inc.1
Biodynamics Corp.1
Boehringer Mannheim Corp.1
Diagnostic Specialties1
Em Diagnostic Systems, Inc.1
King Diagnostics, Inc.1
Mallinckrodt Critical Care1
Prisma Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code