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Orgentec

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K954831 ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAYLKO1996-05-08 View
510(k) K954830 ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYLKP1996-05-08 View
510(k) K954815 ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAYLJM1996-04-18 View
510(k) K954829 ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAYLJM1996-04-18 View
510(k) K954814 ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAYLJM1996-04-18 View
510(k) K954832 ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAYLJM1996-04-18 View
510(k) K960274 ORGENTEC MICRO-ALBUMIN PIN EIA ASSAYJIR1996-03-29 View
510(k) K955134 ORGENTEC ENASCREEN ELISA ASSAYLLL1996-03-20 View
510(k) K955133 ORGENTEC ENASCREEN PIN IMMUNO ASSAYLLL1996-03-20 View
510(k) K953671 ORGEN TEC ANTI-DSDNA ELISA ASSAYLRM1995-11-09 View
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