Cleared Traditional

HEMATRAK

K770680 · Geometric Data, Div. Smithkline Corp. · Hematology
Jul 1977
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K770680 is an FDA 510(k) clearance for the HEMATRAK, 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 July 1, 1977, 81 days after receiving the submission on April 11, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K770680 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1977
Decision Date July 01, 1977
Days to Decision 81 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