Atlas FDA

GGT

20 FDA 510(k) clearances · Product code

215 daysmedian time to decision
391 days90th percentile
20clearances measured

FDA profile

Official device name
Assay, Erythropoietin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7250
Medical specialty
Hematology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Access EPO (K240182)Beckman Coulter, Inc.2024-04-22
ADVIA Centaur Erythropoietin (EPO) assay (K183088)Axis-Shield Diagnostics Limited2019-08-02
ACCESS EPO ASSAY (K052223)Beckman Coulter, Inc.2006-10-06
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (K992799)Sangui Biotech, Inc.2000-06-07
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (K983203)Diagnostic Products Corp.1999-07-12
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (K980737)Nichols Institute Diagnostics1999-03-23
ERYTHROPOIETIN IMMUNOASSAY KIT (K952559)Nichols Institute1996-05-29
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (K954898)Genzyme Corp.1996-02-05
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K936016)R&D Systems, Inc.1994-07-19
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (K931756)R&D Systems, Inc.1994-04-21
ERYTHROPOIETIN IMMUNOASSAY KIT (K932650)Nichols Institute1994-03-11
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY (K931666)R&D Systems, Inc.1993-07-20
PREDICTA ERYTHROPOIETIN KIT (K926390)Genzyme Corp.1993-06-25
EPO-RIA (K910481)Ramco Laboratories, Inc.1991-11-29
DSL ERYTHROPOIETIN (DSL # 1100) (K903492)Diagnostic Systems Laboratories, Inc.1990-10-26
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) (K902639)Incstar Corp.1990-08-22
EPO-TRAC BY RADIOIMMUNOASSAY (RIA) (K893393)Incstar Corp.1989-11-21
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 (K894943)Amgen, Inc.1989-10-10
ERYTHROPOIETIN ENZYME IMMUNOASSAY (K882686)Amgen, Inc.1988-12-20
ERYTHROPOIETIN EIA (K833957)Jcl Clinical Research Corp.1984-03-23

Track GGT automatically

Every clearance here is in the API, with alerts when new ones post.