FDA 510(k) Applications for Medical Device Product Code "CZN"
(Iga, Fitc, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K831909 DAKO CORP. RABBIT ANTISERUM TO HUMAN IGA 07/18/1983
K832262 GELCO DIAGNOSTICS, INC. FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS 10/31/1983
K832257 GELCO DIAGNOSTICS, INC. GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC 10/28/1983
K891683 HELENA LABORATORIES TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER 04/12/1989
K831607 INTL. DIAGNOSTIC TECHNOLOGY FIAX IGA TEST KIT 06/22/1983
K855011 KALLESTAD LABORATORIES, INC. QUANTIMETRIC PLUS C3 REAGENT KIT 02/26/1986
K841815 MILES LABORATORIES, INC. OPTIMATE IGA TEST 06/01/1984


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