Cleared Traditional

HARRIS HEMATOXYLIN

K872498 · Anatech, Ltd. · Pathology
Jul 1987
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K872498 is an FDA 510(k) clearance for the HARRIS HEMATOXYLIN, a Hematoxylin Harris's (Class I — General Controls, product code HYK), submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on July 9, 1987, 15 days after receiving the submission on June 24, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K872498 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1987
Decision Date July 09, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HYK — Hematoxylin Harris's
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850