Cleared Traditional

HYDRAGEL 15 HB A1C KIT

K963844 · Morax · Hematology
Apr 1997
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K963844 is an FDA 510(k) clearance for the HYDRAGEL 15 HB A1C KIT, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on April 22, 1997, 209 days after receiving the submission on September 25, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K963844 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1996
Decision Date April 22, 1997
Days to Decision 209 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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