Cleared Traditional

STAIN, HEMASTAIN RETIC

K790042 · Geometric Data, Div. Smithkline Corp. · Hematology
Feb 1979
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K790042 is an FDA 510(k) clearance for the STAIN, HEMASTAIN RETIC, a Stain, Reticulocyte (Class I — General Controls, product code GJH), submitted by Geometric Data, Div. Smithkline Corp. (Mchenry, US). The FDA issued a Cleared decision on February 15, 1979, 41 days after receiving the submission on January 5, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K790042 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1979
Decision Date February 15, 1979
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GJH — Stain, Reticulocyte
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850