Cleared Traditional

HEMASPINNER

K811534 · Geometric Data, Div. Smithkline Corp. · Hematology
Aug 1981
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K811534 is an FDA 510(k) clearance for the HEMASPINNER, a Spinner, Slide, Automated (Class I — General Controls, product code GKJ), submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981, 78 days after receiving the submission on June 1, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5850.

Submission Details

510(k) Number K811534 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1981
Decision Date August 18, 1981
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKJ — Spinner, Slide, Automated
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.5850