Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
FDA 510(k) K171664 · Bio-Rad Laboratories, Inc.
510(k) numberK171664
Submission
- Device name
- Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
- Applicant
- Bio-Rad Laboratories, Inc.
Hercules, CA, US - Received
- June 5, 2017
- Decision date
- September 13, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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Questions and answers
When was Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software cleared by the FDA?
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (K171664) received a 510(k) decision of Substantially Equivalent on September 13, 2017, 100 days after the submission was received.
What is the product code of K171664?
The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.