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

Electrode, Ion Based, Enzymatic, Creatinine

21 CFR 862.1225 / Clinical Chemistry
FDA source (opens on fda.gov)

CGL is the FDA product code for Electrode, Ion Based, Enzymatic, Creatinine, a class II device type, regulated under 21 CFR 862.1225. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
CGL
Device name
Electrode, Ion Based, Enzymatic, Creatinine
Regulation
21 CFR 862.1225
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
8
Ingested recalls
9

Clearances, product code CGL

By decision year
8 clearances under product code CGL with a decision year between 1991 and 2026, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CGL by decision year
YearClearances
19911
19971
19991
20061
20071
20121
20171
20261

Applicants with the most clearances

Product code CGL
Applicants holding the most 510(k) clearances under product code CGL
ApplicantClearances
Nova Biomedical Corporation3
Abbott Medical1
Epocal Inc1
I-Stat Corp.1
Radiometer Medical ApS1
Swedish Trade Council USA1

Companies listing this code with FDA

Companies whose registered establishments list this code