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
GGLClass II

Control, White-Cell

21 CFR 864.8625 / Hematology
FDA source (opens on fda.gov)

GGL is the FDA product code for Control, White-Cell, a class II device type, regulated under 21 CFR 864.8625. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GGL
Device name
Control, White-Cell
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code GGL

By decision year
8 clearances under product code GGL with a decision year between 1989 and 2009, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GGL by decision year
YearClearances
19892
19921
19941
19961
19991
20051
20091

Applicants with the most clearances

Product code GGL
Applicants holding the most 510(k) clearances under product code GGL
ApplicantClearances
Streck Laboratories, Inc.4
Streck LLC2
Coulter Corp.1
Elite Diagnostic, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code