Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with

FDA 510(k) K080911 · Bio-Rad Laboratories Inc., Clinical Systems Divisi

Substantially Equivalent

510(k) numberK080911

Submission

Device name
Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with
Applicant
Bio-Rad Laboratories Inc., Clinical Systems Divisi
Hercules, CA, US
Received
April 2, 2008
Decision date
May 2, 2008
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GKA – Abnormal Hemoglobin Quantitation
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7415
Specialty
Hematology

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K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional Helena Laboratories, Corp.04/19/2022SE
K180762Capi 3 Hemoglobin(E)GKA · Traditional Sebia12/14/2018SE
K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special Bio-Rad Laboratories, Inc.09/13/2017SE
K112550Capillarys Hemoglobin, Capillarys Flex Piercing SystemGKA · Traditional Sebia05/25/2012SE
K112491Sebia Capillarys Hemoglobin(E) with Capillarys 2GKA · Traditional Sebia05/24/2012SE
K091283Capillarys Neonat HB (PN 2006)GKA · Traditional Sebia02/22/2010SE
K082227Minicap Hemoglobin(E) Kit, Model 2207, 2227GKA · Traditional Sebia03/26/2009SE
K052291Capillary's Hemoglobin(E) (PN 2007)GKA · Traditional Sebia06/27/2006SE

More from Sebia

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Questions and answers

When was Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with cleared by the FDA?

Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with (K080911) received a 510(k) decision of Substantially Equivalent on May 2, 2008, 30 days after the submission was received.

What is the product code of K080911?

The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.