Product Code: GGT FDA class 2 21 CFR 864.7250

Assay, Erythropoietin

Hematology

Assay, Erythropoietin (product code GGT) is a hematology test used to measure levels of erythropoietin, a hormone that regulates red blood cell production, aiding in the differential diagnosis of anemia and polycythemia. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7250 in the Hematology specialty (HE), it is eligible for third-party review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code GGT in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: GGT
Device Class: FDA class 2
Regulation Number: 864.7250
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240182	Access EPO	Apr 22, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K183088	ADVIA Centaur Erythropoietin (EPO) assay	Aug 02, 2019	Substantially Equivalent	Axis-Shield Diagnostics Limited
K052223	ACCESS EPO ASSAY	Oct 06, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K992799	SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT	Jun 07, 2000	Substantially Equivalent	Sangui Biotech, Inc.
K983203	IMMULITE EPO, MODEL #'S LKEPZ & LKEP1	Jul 12, 1999	Substantially Equivalent	Diagnostic Products Corp.
K980737	ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY	Mar 23, 1999	Substantially Equivalent	Nichols Institute Diagnostics
K952559	ERYTHROPOIETIN IMMUNOASSAY KIT	May 29, 1996	Substantially Equivalent	Nichols Institute
K954898	PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)	Feb 05, 1996	Substantially Equivalent	Genzyme Corp.
K936016	QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)	Jul 19, 1994	Substantially Equivalent	R&D Systems, Inc.
K931756	QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS	Apr 21, 1994	Substantially Equivalent	R&D Systems, Inc.
K932650	ERYTHROPOIETIN IMMUNOASSAY KIT	Mar 11, 1994	Substantially Equivalent	Nichols Institute
K931666	QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY	Jul 20, 1993	Substantially Equivalent	R&D Systems, Inc.
K926390	PREDICTA ERYTHROPOIETIN KIT	Jun 25, 1993	Substantially Equivalent	Genzyme Corp.
K910481	EPO-RIA	Nov 29, 1991	Substantially Equivalent	Ramco Laboratories, Inc.
K903492	DSL ERYTHROPOIETIN (DSL # 1100)	Oct 26, 1990	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K902639	EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)	Aug 22, 1990	Substantially Equivalent	Incstar Corp.
K893393	EPO-TRAC BY RADIOIMMUNOASSAY (RIA)	Nov 21, 1989	Substantially Equivalent	Incstar Corp.
K894943	CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3	Oct 10, 1989	Substantially Equivalent	Amgen, Inc.
K882686	ERYTHROPOIETIN ENZYME IMMUNOASSAY	Dec 20, 1988	Substantially Equivalent	Amgen, Inc.
K833957	ERYTHROPOIETIN EIA	Mar 23, 1984	Substantially Equivalent	Jcl Clinical Research Corp.