Cleared Traditional

K791041 - HEMATRAK ABNORMAL RECOGNITION
(FDA 510(k) Clearance)

K791041 · Geometric Data, Div. Smithkline Corp. · Hematology
Sep 1979
Decision
91d
Days
Class 2
Risk

K791041 is an FDA 510(k) clearance for the HEMATRAK ABNORMAL RECOGNITION, 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 September 4, 1979, 91 days after receiving the submission on June 5, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K791041 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1979
Decision Date September 04, 1979
Days to Decision 91 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