510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
JPZClass I

Colorimetric Method, Gamma-Glutamyl Transpeptidase

21 CFR 862.1360 / Clinical Chemistry
FDA source (opens on fda.gov)

JPZ is the FDA product code for Colorimetric Method, Gamma-Glutamyl Transpeptidase, a class I device type, regulated under 21 CFR 862.1360. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JPZ
Device name
Colorimetric Method, Gamma-Glutamyl Transpeptidase
Regulation
21 CFR 862.1360
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
33
Ingested recalls
0

Clearances, product code JPZ

By decision year
33 clearances under product code JPZ with a decision year between 1976 and 2002, 1986 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code JPZ by decision year
YearClearances
19764
19782
19791
19811
19824
19831
19841
19851
19867
19871
19882
19891
19902
19911
19922
19961
20021

Applicants with the most clearances

Product code JPZ
Applicants holding the most 510(k) clearances under product code JPZ
ApplicantClearances
Data Medical Associates, Inc.3
Harleco2
Technostics Intl.2
FUJIFILM Healthcare Americas Corporation2
Abbott Medical1
Advocacy International, Ltd.1
Amresco, Inc.1
Calbiochem1
Careside, Inc.1
Coulter Electronics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order