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

Tray, Blood Collection

21 CFR 862.1675 / Clinical Chemistry
FDA source (opens on fda.gov)

GJE is the FDA product code for Tray, Blood Collection, a class II device type, regulated under 21 CFR 862.1675. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GJE
Device name
Tray, Blood Collection
Regulation
21 CFR 862.1675
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
7
Ingested recalls
1

Clearances, product code GJE

By decision year
7 clearances under product code GJE with a decision year between 1976 and 1996, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GJE by decision year
YearClearances
19761
19773
19781
19941
19961

Applicants with the most clearances

Product code GJE
Applicants holding the most 510(k) clearances under product code GJE
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic3
Bio/Data Corp.1
Concord Laboratories, Inc.1
Customed, Inc1
J.J. Skinner, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code