Cleared Traditional

K790816 - HEMATRAK MODEL 480
(FDA 510(k) Clearance)

K790816 · Geometric Data, Div. Smithkline Corp. · Hematology
Jul 1979
Decision
81d
Days
Class 2
Risk

K790816 is an FDA 510(k) clearance for the HEMATRAK MODEL 480, 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 17, 1979, 81 days after receiving the submission on April 27, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K790816 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1979
Decision Date July 17, 1979
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