Cleared Traditional

K780577 - PLATELETS/CU MM
(FDA 510(k) Clearance)

K780577 · Geometric Data, Div. Smithkline Corp. · Hematology
May 1978
Decision
39d
Days
Class 2
Risk

K780577 is an FDA 510(k) clearance for the PLATELETS/CU MM. This device is classified as 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 May 19, 1978, 39 days after receiving the submission on April 10, 1978.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K780577 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1978
Decision Date May 19, 1978
Days to Decision 39 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