Cleared Traditional

ANATECH HEMATOXYLIN-EXTRA STRENGTH

K872500 · Anatech, Ltd. · Pathology

Jul 1987

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K872500 is an FDA 510(k) clearance for the ANATECH HEMATOXYLIN-EXTRA STRENGTH, a Hematoxylin (Class I — General Controls, product code HYJ), 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	K872500 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	—