Cleared Traditional

HEMATOXYLIN STAIN HARRIS

K781585 · Bioscientific · Pathology
Oct 1978
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K781585 is an FDA 510(k) clearance for the HEMATOXYLIN STAIN HARRIS, a Hematoxylin Harris's (Class I — General Controls, product code HYK), submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978, 22 days after receiving the submission on September 18, 1978. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K781585 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1978
Decision Date October 10, 1978
Days to Decision 22 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