Cleared Traditional

ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION

K770869 · Geometric Data, Div. Smithkline Corp. · Hematology
Jun 1977
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K770869 is an FDA 510(k) clearance for the ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION, 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 2, 1977, 20 days after receiving the submission on May 13, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K770869 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1977
Decision Date June 02, 1977
Days to Decision 20 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