FDA 510(k)

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

K-번호: K171664 · 2017-09-13

결정일2017-09-13

제품 코드GKA

자문 위원회HE

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Bio-Rad Laboratories, Inc.를 신청인으로 등재한 기타 기록

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

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