Cleared Traditional

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

K924496 · Drew Scientific , Ltd. · Hematology
Nov 1992
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K924496 is an FDA 510(k) clearance for the GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT, a Hemoglobin A2 Quantitation (Class II — Special Controls, product code JPD), submitted by Drew Scientific , Ltd. (London W4 4ph Uk, GB). The FDA issued a Cleared decision on November 16, 1992, 73 days after receiving the submission on September 4, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7400.

Submission Details

510(k) Number K924496 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1992
Decision Date November 16, 1992
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JPD — Hemoglobin A2 Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7400

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