DDZ · Class II · 21 CFR 866.5040

FDA Product Code DDZ: Albumin, Fitc, Antigen, Antiserum, Control

Leading manufacturers include Randox Laboratories, Ltd., Pointe Scientific, Inc., and Dako Corp..

4
Total
4
Cleared
69d
Avg days
1983
Since

FDA 510(k) Cleared Albumin, Fitc, Antigen, Antiserum, Control Devices (Product Code DDZ)

4 devices
1–4 of 4
Cleared Apr 28, 2003
MICROALBUMIN REAGENT SET AND CALIBRATORS
K023860
Pointe Scientific, Inc.,
Chemistry · 159d
Cleared Oct 05, 2000
RANDOX MICROALBUMIN
K002674
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Jul 18, 1983
FLUORESCEIN CONJUGATED IMMUNOGLOBIN-
K831902
Dako Corp.
Immunology · 34d

About Product Code DDZ - Regulatory Context