Home / Device Classification / GKA

GKA — Abnormal Hemoglobin Quantitation Class II

FDA Device Classification

Classification Details

Product Code
GKA
Device Class
Class II
Regulation Number
864.7415
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232027sebiaCAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentApril 4, 2024
K222635trinity biotech (primus corporation, dba trinity biotech)Premier Resolution SystemAugust 4, 2023
K192931helena laboratoriesV8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlApril 19, 2022
K180762sebiaCAPI 3 HEMOGLOBIN(E)December 14, 2018
K171664bio-rad laboratoriesHemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoSeptember 13, 2017
K112550sebiaCAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMMay 25, 2012
K112491sebiaSEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2May 24, 2012
K091283sebiaCAPILLARYS NEONAT HB (PN 2006)February 22, 2010
K082227sebiaMINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227March 26, 2009
K080911bio-rad laboratories inc., clinical systems divisiVARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEMay 2, 2008
K052291sebiaCAPILLARY'S HEMOGLOBIN(E) (PN 2007)June 27, 2006
K050709wallacRESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, March 8, 2006
K051072bio-rad laboratoriesBIO-RAD VARIANT NBS SICKLE CELL PROGRAMMay 12, 2005
K040146interlabINTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMMay 4, 2004
K955355bio-radVARIANT ALPHA-THALASSEMIA SHORT PROGRAMApril 26, 1996
K955283primusPRIMUS VARIANT SYSTEM PVS99March 1, 1996
K954048bio-radVARIANT HEMOGLOBINOPATHY PROGRAMNovember 20, 1995
K924813bio-radVARIANT SICKLE CELL SHORT PROGRAMJanuary 14, 1993
K834595beckman instrumentsPARAGON ACID HEMOGLOBIN REAGENT KITMay 7, 1984
K840011isolabRESOLVE-HBFebruary 4, 1984