Cleared Traditional

HYCEL QUICK-LYSING HEMOGLOBIN REAGENT

K882490 · R&D Systems, Inc. · Hematology
Jul 1988
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K882490 is an FDA 510(k) clearance for the HYCEL QUICK-LYSING HEMOGLOBIN REAGENT, a Diluent, Blood Cell (Class I — General Controls, product code GIF), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 25, 1988, 39 days after receiving the submission on June 16, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8200.

Submission Details

510(k) Number K882490 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1988
Decision Date July 25, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIF — Diluent, Blood Cell
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8200