Cleared Traditional

ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)

K881042 · Alpha-Tec Systems, Inc. · Pathology

Mar 1988

Decision

19d

Days

Class 1

Risk

About This 510(k) Submission

K881042 is an FDA 510(k) clearance for the ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION), a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on March 30, 1988, 19 days after receiving the submission on March 11, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K881042 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 1988
Decision Date	March 30, 1988
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—