Cleared Traditional

HARRIS HEMATOXYLIN

K810733 · Surgipath · Pathology
Apr 1981
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K810733 is an FDA 510(k) clearance for the HARRIS HEMATOXYLIN, a Hematoxylin Harris's (Class I — General Controls, product code HYK), submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on April 14, 1981, 27 days after receiving the submission on March 18, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K810733 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1981
Decision Date April 14, 1981
Days to Decision 27 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