Product code GGT— Hematology

FDA has cleared 20 devices under product code GGT between 1984 and 2024, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20241 clearance
• 20191 clearance
• 20061 clearance
• 20001 clearance
• 19992 clearances
• 19962 clearances
• 19943 clearances
• 19932 clearances
• 19911 clearance
• 19902 clearances
• 19892 clearances
• 19881 clearance
• 19841 clearance

• R&D Systems, Inc.3 clearances
• Nichols Institute2 clearances
• Incstar Corp.2 clearances
• Genzyme Corp.2 clearances
• Beckman Coulter, Inc.2 clearances
• Amgen, Inc.2 clearances
• Sangui Biotech, Inc.1 clearance
• Ramco Laboratories, Inc.1 clearance
• Nichols Institute Diagnostics1 clearance
• Jcl Clinical Research Corp.1 clearance

• K240182 — Access EPOBeckman Coulter, Inc.·2024-04-22
• K183088 — ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited·2019-08-02
• K052223 — ACCESS EPO ASSAYBeckman Coulter, Inc.·2006-10-06
• K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITSangui Biotech, Inc.·2000-06-07
• K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP1Diagnostic Products Corp.·1999-07-12
• K980737 — ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYNichols Institute Diagnostics·1999-03-23
• K952559 — ERYTHROPOIETIN IMMUNOASSAY KITNichols Institute·1996-05-29
• K954898 — PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)Genzyme Corp.·1996-02-05
• K936016 — QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)R&D Systems, Inc.·1994-07-19
• K931756 — QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLSR&D Systems, Inc.·1994-04-21
• K932650 — ERYTHROPOIETIN IMMUNOASSAY KITNichols Institute·1994-03-11
• K931666 — QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAYR&D Systems, Inc.·1993-07-20
• K926390 — PREDICTA ERYTHROPOIETIN KITGenzyme Corp.·1993-06-25
• K910481 — EPO-RIARamco Laboratories, Inc.·1991-11-29
• K903492 — DSL ERYTHROPOIETIN (DSL # 1100)Diagnostic Systems Laboratories, Inc.·1990-10-26
• K902639 — EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)Incstar Corp.·1990-08-22
• K893393 — EPO-TRAC BY RADIOIMMUNOASSAY (RIA)Incstar Corp.·1989-11-21
• K894943 — CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3Amgen, Inc.·1989-10-10
• K882686 — ERYTHROPOIETIN ENZYME IMMUNOASSAYAmgen, Inc.·1988-12-20
• K833957 — ERYTHROPOIETIN EIAJcl Clinical Research Corp.·1984-03-23