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

Turbidimetric Method, Globulin

21 CFR 862.1330 / Clinical Chemistry
FDA source (opens on fda.gov)

JGE is the FDA product code for Turbidimetric Method, Globulin, a class I device type, regulated under 21 CFR 862.1330. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
JGE
Device name
Turbidimetric Method, Globulin
Regulation
21 CFR 862.1330
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
1
Ingested recalls
1

Clearances, product code JGE

By decision year
1 clearance under product code JGE with a decision year between 1998 and 1998, 1998 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JGE by decision year
YearClearances
19981

Applicants with the most clearances

Product code JGE
Applicants holding the most 510(k) clearances under product code JGE
ApplicantClearances
Exigent Diagnostics, 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 JGE.