Cleared Traditional

EA 65

K812086 · Surgipath · Pathology
Aug 1981
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K812086 is an FDA 510(k) clearance for the EA 65, a Stain, Papanicolau (Class I — General Controls, product code HZJ), submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 22 days after receiving the submission on July 22, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K812086 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1981
Decision Date August 13, 1981
Days to Decision 22 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