Cleared Traditional

PAP STAIN, OG-6

K842736 · E K Ind., Inc. · Pathology
Aug 1984
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K842736 is an FDA 510(k) clearance for the PAP STAIN, OG-6, 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 August 17, 1984, 35 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 K842736 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1984
Decision Date August 17, 1984
Days to Decision 35 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