Cleared Traditional

K893772 - TISSUE EMBEDDING MEDIUM
(FDA 510(k) Clearance)

K893772 · Stephens Scientific · Pathology

Jun 1989

Decision

31d

Days

Class 1

Risk

K893772 is an FDA 510(k) clearance for the TISSUE EMBEDDING MEDIUM, a Formulations, Paraffin, All (Class I — General Controls, product code KEO), submitted by Stephens Scientific (Denville, US). The FDA issued a Cleared decision on June 22, 1989, 31 days after receiving the submission on May 22, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K893772 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 1989
Decision Date	June 22, 1989
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—