Cleared Traditional

BLOOD-SMEARING INSTRUMENT (MINIPREP TM)

K760007 · Geometric Data, Div. Smithkline Corp. · Hematology
Sep 1976
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K760007 is an FDA 510(k) clearance for the BLOOD-SMEARING INSTRUMENT (MINIPREP TM), 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 September 3, 1976, 87 days after receiving the submission on June 8, 1976. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5850.

Submission Details

510(k) Number K760007 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1976
Decision Date September 03, 1976
Days to Decision 87 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