Cleared Traditional

GILL'S HEMATOXYLIN #1

K810758 · Surgipath · Pathology
Apr 1981
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K810758 is an FDA 510(k) clearance for the GILL'S HEMATOXYLIN #1, a Hematoxylin (Class I — General Controls, product code HYJ), submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on April 14, 1981, 25 days after receiving the submission on March 20, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K810758 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1981
Decision Date April 14, 1981
Days to Decision 25 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