Cleared Traditional

GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6

K843427 · Accra Laboratories, Inc. · Pathology

Oct 1984

Decision

28d

Days

Class 1

Risk

About This 510(k) Submission

K843427 is an FDA 510(k) clearance for the GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6, a Stain, Papanicolau (Class I — General Controls, product code HZJ), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1984, 28 days after receiving the submission on September 4, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K843427 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 1984
Decision Date	October 02, 1984
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—