Ats Mayer's Albumin

FDA 510(k) K890022 · Alpha-Tec Systems, Inc.

Substantially Equivalent

510(k) numberK890022

Submission

Device name
Ats Mayer's Albumin
Applicant
Alpha-Tec Systems, Inc.
Irvine, CA, US
Received
January 4, 1989
Decision date
January 10, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KEL – Adhesive, Albumin-Based
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

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Questions and answers

When was Ats Mayer's Albumin cleared by the FDA?

Ats Mayer's Albumin (K890022) received a 510(k) decision of Substantially Equivalent on January 10, 1989, 6 days after the submission was received.

What is the product code of K890022?

The FDA product code is KEL – Adhesive, Albumin-Based, a Class I (low risk) device regulated under 21 CFR 864.4010.