Cleared Traditional

COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II

K883836 · Coulter Immunology · Hematology
Nov 1988
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K883836 is an FDA 510(k) clearance for the COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on November 30, 1988, 79 days after receiving the submission on September 12, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number K883836 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1988
Decision Date November 30, 1988
Days to Decision 79 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