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
GGOClass II

Reagent, Thromboplastin And Control

21 CFR 864.7925 / Hematology
FDA source (opens on fda.gov)

GGO is the FDA product code for Reagent, Thromboplastin And Control, a class II device type, regulated under 21 CFR 864.7925. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GGO
Device name
Reagent, Thromboplastin And Control
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code GGO

By decision year
1 clearance under product code GGO with a decision year between 2001 and 2001, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GGO by decision year
YearClearances
20011

Applicants with the most clearances

Product code GGO
Applicants holding the most 510(k) clearances under product code GGO
ApplicantClearances
Sigma Diagnostics, 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 GGO.