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Seragen Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K872148 VIVID CHLAMYDIA(TM)LJC1987-08-19 View
510(k) K851663 QUICK-COUNT HEMATOLOGY CONTROLSJPK1985-07-23 View
510(k) K852260 QUICK-CHEM CALIBRATION SETJIW1985-07-22 View
510(k) K851520 CK/LD ISOENZYMES CONTROLS(HUMAN)JJT1985-06-25 View
510(k) K851521 LD-1(IMMUNO) SEPARATION SETCEX1985-05-10 View
510(k) K850209 QUICK-LYTEJGS1985-02-27 View
510(k) K844743 SERATEST ENA(RNP/SM) DETERMINATIONLLL1985-02-04 View
510(k) K842563 SERATEST DNA DETERMINATIONLKJ1984-10-25 View
510(k) K841504 QUICK-COUNT PLUS 2GKL1984-06-11 View
510(k) K840793 CK/MB IMMUNO-ISOENZYME CONTROL SERUMJJT1984-04-13 View
510(k) K840863 SERATEST RF LATEX DETERMINATIONDHR1984-04-04 View
510(k) K834396 DIRECT IRON REAGENT SETCFM1984-02-21 View
510(k) K833972 QUICK-COUNT HEMATOLOGY REAGENT KITGIF1984-02-17 View
510(k) K833971 QUICK-COUNTGKL1984-01-30 View
510(k) K833744 ALKALINE PHOSPHATASE-RATECJE1984-01-13 View
510(k) K833931 UREA NITROGEN-UVCDQ1984-01-13 View
510(k) K832926 ENZYMATIC GLUCOSE DETERMINATIONCGA1983-10-28 View
510(k) K832759 TOTAL IRON-BINDING CAPACITY ACCESORYJMO1983-10-14 View
510(k) K831525 H-FLU B ELISA TESTGRP1983-09-29 View
510(k) K822115 SERAGAN ACTH125 I-RIA KITCKG1982-10-18 View
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