Cleared Traditional

HEMOLYSE

K863503 · Reagent Laboratory, Inc. · Hematology
Oct 1986
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K863503 is an FDA 510(k) clearance for the HEMOLYSE, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by Reagent Laboratory, Inc. (Louisville, US). The FDA issued a Cleared decision on October 3, 1986, 24 days after receiving the submission on September 9, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number K863503 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1986
Decision Date October 03, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGK — Products, Red-cell Lysing Products
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8540

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