Cleared Traditional

HEMATOXYLIN GILL FORMULATION IX#56016

K831090 · Accra Laboratories, Inc. · Pathology
Jun 1983
Decision
65d
Days
Class 1
Risk

About This 510(k) Submission

K831090 is an FDA 510(k) clearance for the HEMATOXYLIN GILL FORMULATION IX#56016, a Hematoxylin (Class I — General Controls, product code HYJ), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 65 days after receiving the submission on April 4, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K831090 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1983
Decision Date June 08, 1983
Days to Decision 65 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HYJ — Hematoxylin
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850