Cleared Traditional

GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT

K864643 · Pacific Hemostasis · Hematology
Apr 1987
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K864643 is an FDA 510(k) clearance for the GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Pacific Hemostasis (Ventura, US). The FDA issued a Cleared decision on April 28, 1987, 153 days after receiving the submission on November 26, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K864643 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1986
Decision Date April 28, 1987
Days to Decision 153 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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

Similar Devices — LCP Assay, Glycosylated Hemoglobin

All 248
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
K221326 · Nova Biomedical Corporation · Nov 2024
Q-Pad Test System
K231465 · Qurasense · Dec 2023
Afinion? HbA1c, Afinion? 2 and Alere Afinion? AS100 Analyzer
K214117 · Abbott Diagnostics Technologies AS · Sep 2023
Aina HbA1c Monitoring System 2
K192987 · Jana Care, Inc. · Mar 2020
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369 · Ixensor Co, Ltd. · Oct 2019
OneDraw A1C Test System
K183230 · Drawbridge Health, Inc. · Aug 2019