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

Orthotoluidine, Glucose

21 CFR 862.1345 / Clinical Chemistry
FDA source (opens on fda.gov)

CGE is the FDA product code for Orthotoluidine, Glucose, a class II device type, regulated under 21 CFR 862.1345. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CGE
Device name
Orthotoluidine, Glucose
Regulation
21 CFR 862.1345
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
12
Ingested recalls
0

Clearances, product code CGE

By decision year
12 clearances under product code CGE with a decision year between 1977 and 1989, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CGE by decision year
YearClearances
19773
19781
19791
19812
19821
19841
19851
19861
19891

Applicants with the most clearances

Product code CGE
Applicants holding the most 510(k) clearances under product code CGE
ApplicantClearances
Alpkem Corp.1
Analytical & Research Chemicals, Inc.1
Anco Medical Reagents & Assoc.1
Dilab, Inc.1
Fisher Scientific Company L.L.C.1
Harleco1
Icn Pharmaceuticals, Inc.1
King Diagnostics, Inc.1
Mallinckrodt Critical Care1
Medical Specialties Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code CGE.