FDA 510(k) Applications Submitted by ORGENTEC

FDA 510(k) Number Submission Date Device Name Applicant
K960274 01/19/1996 ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY ORGENTEC
K954814 10/19/1995 ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY ORGENTEC
K954815 10/19/1995 ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY ORGENTEC
K954829 10/20/1995 ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY ORGENTEC
K954830 10/20/1995 ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY ORGENTEC
K954831 10/20/1995 ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY ORGENTEC
K954832 10/20/1995 ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY ORGENTEC
K955133 11/09/1995 ORGENTEC ENASCREEN PIN IMMUNO ASSAY ORGENTEC
K955134 11/09/1995 ORGENTEC ENASCREEN ELISA ASSAY ORGENTEC


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