Cleared Traditional

PAPINCOLABU STAIN EA-36/50/65 & OG-6

K823329 · Accra Laboratories, Inc. · Pathology

Dec 1982

Decision

50d

Days

Class 1

Risk

About This 510(k) Submission

K823329 is an FDA 510(k) clearance for the PAPINCOLABU STAIN EA-36/50/65 & OG-6, a Phloxine B (Class I — General Controls, product code HZL), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 50 days after receiving the submission on November 8, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K823329 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 1982
Decision Date	December 28, 1982
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—