KEL · Class I · 21 CFR 864.4010

FDA Product Code KEL: Adhesive, Albumin-based

Leading manufacturers include Stat Path and Alpha-Tec Systems, Inc..

2
Total
2
Cleared
9d
Avg days
1988
Since

FDA 510(k) Cleared Adhesive, Albumin-based Devices (Product Code KEL)

2 devices
1–2 of 2
Cleared Jan 10, 1989
ATS MAYER'S ALBUMIN
K890022
Alpha-Tec Systems, Inc.
Pathology · 6d
Cleared Apr 18, 1988
HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED
K881477
Stat Path
Pathology · 11d

About Product Code KEL - Regulatory Context