Cleared Traditional

ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION

K880990 · Alpha-Tec Systems, Inc. · Pathology

Mar 1988

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K880990 is an FDA 510(k) clearance for the ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION, a Kit, Identification, Mycobacteria (Class I — General Controls, product code JSY), submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on March 24, 1988, 16 days after receiving the submission on March 8, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K880990 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 1988
Decision Date	March 24, 1988
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—