Cleared Traditional

MODIFIED EA 50

K820027 · Surgipath · Pathology
Feb 1982
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K820027 is an FDA 510(k) clearance for the MODIFIED EA 50, a Stain, Papanicolau (Class I — General Controls, product code HZJ), submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982, 30 days after receiving the submission on January 5, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K820027 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1982
Decision Date February 04, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HZJ — Stain, Papanicolau
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850