Adhesive, Albumin-Based

FDA product code KEL · Class I (low risk) · 21 CFR 864.4010 · Pathology

2510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K890022Ats Mayer's AlbuminKEL · Traditional Alpha-Tec Systems, Inc.01/10/1989SE
K881477Histogrip & Histogrip Gold Concentrate/PredilutedKEL · Traditional Stat Path04/18/1988SE