CZN · Class II · 21 CFR 866.5510

FDA Product Code CZN: Iga, Fitc, Antigen, Antiserum, Control

Leading manufacturers include Gelco Diagnostics, Inc., Intl. Diagnostic Technology and Dako Corp..

7
Total
7
Cleared
62d
Avg days
1983
Since

FDA 510(k) Cleared Iga, Fitc, Antigen, Antiserum, Control Devices (Product Code CZN)

7 devices
1–7 of 7
Cleared Apr 12, 1989
TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
K891683
Helena Laboratories
Immunology · 21d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS C3 REAGENT KIT
K855011
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Jun 01, 1984
OPTIMATE IGA TEST
K841815
Miles Laboratories, Inc.
Immunology · 31d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS
K832262
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 28, 1983
GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
K832257
Gelco Diagnostics, Inc.
Immunology · 120d
Cleared Jul 18, 1983
RABBIT ANTISERUM TO HUMAN IGA
K831909
Dako Corp.
Immunology · 34d
Cleared Jun 22, 1983
FIAX IGA TEST KIT
K831607
Intl. Diagnostic Technology
Immunology · 35d

About Product Code CZN - Regulatory Context