Cleared Traditional

K823328 - HARRIS HEMATOXYLIN
(FDA 510(k) Clearance)

K823328 · Accra Laboratories, Inc. · Pathology device

Dec 1982

Decision

50d

Days

Class 1

Risk

K823328 is an FDA 510(k) clearance for the HARRIS HEMATOXYLIN. This device is classified as a Hematoxylin Harris's (Class I - General Controls, product code HYK).

Submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 50 days after receiving the submission on November 8, 1982.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K823328 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 08, 1982
Decision Date	December 28, 1982
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—