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510(k) K955355

Device
Variant Alpha-thalassemia Short Program
Applicant
BIO-RAD
510(k) number
K955355
Product code
GKA
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-26
Date received
1995-11-21
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
KENNETH J KISCO
Address
4000 Alfred Nobel Dr. Hercules CA US 94547 94547

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
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K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp.2022-04-19
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
K955283PRIMUS VARIANT SYSTEM PVS99Primus Corp.1996-03-01