Cleared Traditional

ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID

K883062 · Alpha-Tec Systems, Inc. · Pathology

Aug 1988

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K883062 is an FDA 510(k) clearance for the ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID, a Fixative, Acid Containing (Class I — General Controls, product code LDW), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on August 4, 1988, 16 days after receiving the submission on July 19, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K883062 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 1988
Decision Date	August 04, 1988
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—