Cleared Traditional

HEMATRAK RBC MORPHOLOGY

K761207 · Geometric Data, Div. Smithkline Corp. · Hematology
Oct 1977
Decision
315d
Days
Class 2
Risk

About This 510(k) Submission

K761207 is an FDA 510(k) clearance for the HEMATRAK RBC MORPHOLOGY, 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 October 18, 1977, 315 days after receiving the submission on December 7, 1976. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K761207 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1976
Decision Date October 18, 1977
Days to Decision 315 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