DKA · Class II · 21 CFR 862.3320

FDA Product Code DKA: Antiserum, Digoxin

Leading manufacturers include Pcl-Ria, Inc. and Baxter Diagnostics, Inc..

3
Total
3
Cleared
164d
Avg days
1978
Since

FDA 510(k) Cleared Antiserum, Digoxin Devices (Product Code DKA)

3 devices
1–3 of 3
Cleared Nov 22, 1994
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
K934003
Baxter Diagnostics, Inc.
Toxicology · 462d
Cleared Mar 17, 1978
RABBIT ANTIBODY TO DIGOXIN
K780316
Pcl-Ria, Inc.
Toxicology · 21d

About Product Code DKA - Regulatory Context