Cleared Traditional

ATYPIA PROFILE MONITOR

K770550 · Geometric Data, Div. Smithkline Corp. · Hematology
Jun 1977
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K770550 is an FDA 510(k) clearance for the ATYPIA PROFILE MONITOR, 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 17, 1977, 88 days after receiving the submission on March 21, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K770550 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1977
Decision Date June 17, 1977
Days to Decision 88 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