Cleared Traditional

K770701 - HEMATRAK MODEL 125
(FDA 510(k) Clearance)

K770701 · Geometric Data, Div. Smithkline Corp. · Hematology
Jun 1977
Decision
46d
Days
Class 2
Risk

K770701 is an FDA 510(k) clearance for the HEMATRAK MODEL 125, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1977, 46 days after receiving the submission on April 18, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K770701 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1977
Decision Date June 03, 1977
Days to Decision 46 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220