Cleared Traditional

K890022 - ATS MAYER'S ALBUMIN
(FDA 510(k) Clearance)

K890022 · Alpha-Tec Systems, Inc. · Pathology
Jan 1989
Decision
6d
Days
Class 1
Risk

K890022 is an FDA 510(k) clearance for the ATS MAYER'S ALBUMIN. This device is classified as a Adhesive, Albumin-based (Class I — General Controls, product code KEL).

Submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on January 10, 1989, 6 days after receiving the submission on January 4, 1989.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K890022 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1989
Decision Date January 10, 1989
Days to Decision 6 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KEL — Adhesive, Albumin-based
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010