Cleared Traditional

ATS TB RAPID STAIN SET PRODUCT #034-45

K890148 · Alpha-Tec Systems, Inc. · Pathology

Jan 1989

Decision

11d

Days

Class 1

Risk

About This 510(k) Submission

K890148 is an FDA 510(k) clearance for the ATS TB RAPID STAIN SET PRODUCT #034-45, a Carbol Fuchsin (Class I — General Controls, product code ICL), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on January 24, 1989, 11 days after receiving the submission on January 13, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K890148 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 1989
Decision Date	January 24, 1989
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—