Cleared Special

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

K171664 · Bio-Rad Laboratories, Inc. · Hematology
Sep 2017
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K171664 is an FDA 510(k) clearance for the Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on September 13, 2017, 100 days after receiving the submission on June 5, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K171664 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2017
Decision Date September 13, 2017
Days to Decision 100 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKA — Abnormal Hemoglobin Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

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