Cleared Traditional

PAP STAIN EA-65

K842735 · E K Ind., Inc. · Pathology
Sep 1984
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K842735 is an FDA 510(k) clearance for the PAP STAIN EA-65, a Stain, Papanicolau (Class I — General Controls, product code HZJ), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984, 60 days after receiving the submission on July 13, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K842735 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1984
Decision Date September 11, 1984
Days to Decision 60 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