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

O-Phthalaldehyde, Urea Nitrogen

21 CFR 862.1770 / Clinical Chemistry
FDA source (opens on fda.gov)

JGZ is the FDA product code for O-Phthalaldehyde, Urea Nitrogen, a class II device type, regulated under 21 CFR 862.1770. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JGZ
Device name
O-Phthalaldehyde, Urea Nitrogen
Regulation
21 CFR 862.1770
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
11
Ingested recalls
0

Clearances, product code JGZ

By decision year
11 clearances under product code JGZ with a decision year between 1977 and 1990, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JGZ by decision year
YearClearances
19771
19791
19801
19811
19821
19842
19861
19891
19902

Applicants with the most clearances

Product code JGZ
Applicants holding the most 510(k) clearances under product code JGZ
ApplicantClearances
Roche Diagnostic Systems, Inc.2
American Monitor Corp.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Bio-Analytics Laboratories, Inc.1
Connecticut Diagnostics, Ltd.1
Kulzer GmbH1
King Diagnostics, Inc.1
Miles Laboratories, Inc.1
Pharmacia, Inc.1
Sclavo, 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 JGZ.