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
GGJClass I

Fluid, Diluting, White-Cell

21 CFR 864.8200 / Hematology
FDA source (opens on fda.gov)

GGJ is the FDA product code for Fluid, Diluting, White-Cell, a class I device type, regulated under 21 CFR 864.8200. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GGJ
Device name
Fluid, Diluting, White-Cell
Regulation
21 CFR 864.8200
Device class
Class I
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
1
Ingested recalls
0

Clearances, product code GGJ

By decision year
1 clearance under product code GGJ with a decision year between 1993 and 1993, 1993 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GGJ by decision year
YearClearances
19931

Applicants with the most clearances

Product code GGJ
Applicants holding the most 510(k) clearances under product code GGJ
ApplicantClearances
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code