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Immunodiagnostic Systems , Ltd.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K202136 IDS CortisolCGR2021-04-13 View
510(k) K200475 IDS-iSYS Ostase BAPCIN2020-09-30 View
510(k) K190121 IDS SHBGCDZ2019-06-17 View
510(k) K161158 IDS-iSYS Intact PTHNCEW2017-01-31 View
510(k) K161831 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG2016-11-15 View
510(k) K161082 IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX2016-05-17 View
510(k) K123763 IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSCIB2013-12-24 View
510(k) K123253 IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN DMRG2013-06-18 View
510(k) K122141 IDS-ISYS IGF-I CALIBRATION VERIFIERSJJX2012-08-07 View
510(k) K111938 IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...JJX2012-02-14 View
510(k) K103325 IDS-ISYS INTACT PTHCEW2012-02-03 View
510(k) K111650 IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...JJX2011-09-06 View
510(k) K110412 IDS-ISYS IFG-I CONTROL SETJJX2011-03-16 View
510(k) K051110 1,25-DIHYDROXY VITAMIN D EIAMRG2005-07-06 View
510(k) K042519 GAMMA-B 1,25-DIHYDROXY VITAMIN DMRG2004-12-01 View
510(k) K021163 OCTEIA 25-HYDROXY VITAMIN DMRG2002-05-10 View
510(k) K991998 GAMMA-B 25-HYDROXY VITAMIN D RIAMRG1999-09-17 View
510(k) K950510 OCTEIA IGF-1 KITCFL1995-04-05 View
510(k) K942369 GAMMA-BCT INTACT PTHCEW1994-09-20 View
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