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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 the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2017-09-13 under 510(k) 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. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K171664.

When did Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software receive FDA 510(k) clearance?

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

Who is the listed applicant for Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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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.

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