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510(k) K192931

Device
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
Applicant
Helena Laboratories, Corp.
510(k) number
K192931
Product code
GKA
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-19
Date received
2019-10-17
Regulation
864.7415
Classification name
Abnormal Hemoglobin Quantitation
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Justin Padia
Address
1530 Lingbergh Dr. Beaumont TX US 77707 77707

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GKA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebia2024-04-04
K222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech)2023-08-04
K180762CAPI 3 HEMOGLOBIN(E)Sebia2018-12-14
K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.2017-09-13
K112550CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMSebia2012-05-25
K112491SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2Sebia2012-05-24
K091283CAPILLARYS NEONAT HB (PN 2006)Sebia2010-02-22
K082227MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227Sebia2009-03-26
K080911VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITHBio-Rad Laboratories Inc., Clinical Systems Divisi2008-05-02
K052291CAPILLARY'S HEMOGLOBIN(E) (PN 2007)Sebia2006-06-27
K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367Wallac OY2006-03-08
K051072BIO-RAD VARIANT NBS SICKLE CELL PROGRAMBio-Rad Laboratories, Inc.2005-05-12
K040146INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.2004-05-04
K955355VARIANT ALPHA-THALASSEMIA SHORT PROGRAMBio-Rad1996-04-26
K955283PRIMUS VARIANT SYSTEM PVS99Primus Corp.1996-03-01