Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

K-Number: K171664 · 2017-09-13

ApplicantBio-Rad Laboratories, Inc.
Decision Date2017-09-13
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software is a medical device manufactured by Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2017-09-13 under approval number K171664. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software?

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software is a medical device that received FDA 510(k) clearance on 2017-09-13. It is manufactured by Bio-Rad Laboratories, Inc.. The 510(k) number is K171664.

When was Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software approved by the FDA?

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software received FDA 510(k) clearance on 2017-09-13, under approval number K171664.

What company makes Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software?

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software is manufactured by Bio-Rad Laboratories, Inc..

What is the FDA product code for Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software?

The FDA product code for Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software is GKA.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT04662905 Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025)

Other Devices by Bio-Rad Laboratories, Inc.

K161687D-10 Hemoglobin A1c Program K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

Related Devices (Code: GKA)

K180762CAPI 3 HEMOGLOBIN(E)Sebia K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp. K222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech) K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebia

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑