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

Assay, Erythropoietin

21 CFR 864.7250 / Hematology
FDA source (opens on fda.gov)

GGT is the FDA product code for Assay, Erythropoietin, a class II device type, regulated under 21 CFR 864.7250. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
GGT
Device name
Assay, Erythropoietin
Regulation
21 CFR 864.7250
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
20
Ingested recalls
5

Clearances, product code GGT

By decision year
20 clearances under product code GGT with a decision year between 1984 and 2024, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GGT by decision year
YearClearances
19841
19881
19892
19902
19911
19932
19943
19962
19992
20001
20061
20191
20241

Applicants with the most clearances

Product code GGT
Applicants holding the most 510(k) clearances under product code GGT
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
R & D Systems, Inc.3
Amgen, Inc.2
Genzyme Corporation2
Incstar Corp.2
Nichols Institute2
Axis-Shield Diagnostics, Ltd.1
Diagnostic Systems Laboratories, Inc.1
Jcl Clinical Research Corp.1
Nichols Institute Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code