Medical Device Manufacturer · US , Ellicott City , MD

DiaSorin, Inc. - FDA 510(k) Cleared Devices

70 submissions · 69 cleared · Since 1998
70
Total
69
Cleared
1
Denied

FDA 510(k) cleared devices by DiaSorin, Inc. Chemistry

24 devices
1-24 of 24
Cleared Oct 15, 2020
LIAISON Testosterone xt
K201908 · CDZ
Chemistry · 98d
Cleared May 06, 2020
LIAISON® Folate
K192586 · CGN
Chemistry · 230d
Cleared Oct 02, 2019
LIAISON Vitamin B12
K192064 · CDD
Chemistry · 62d
Cleared Jun 22, 2015
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH...
K150879 · CEW
Chemistry · 82d
Cleared Dec 10, 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463 · MRG
Chemistry · 190d
Cleared Nov 08, 2013
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K132515 · CEW
Chemistry · 88d
Cleared Sep 06, 2013
LIAISON XL HCG
K131037 · DHA
Chemistry · 144d
Cleared Sep 05, 2013
LIAISON 25 TOTAL-D
K132492 · MRG
Chemistry · 27d
Cleared Apr 05, 2013
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON...
K130469 · JLW
Chemistry · 39d
Cleared Apr 04, 2013
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON...
K121951 · CEC
Chemistry · 275d
Cleared Jan 25, 2013
LIAISON TESTOSTERONE
K122793 · CDZ
Chemistry · 135d
Cleared Jan 01, 2013
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
K121944 · CIB
Chemistry · 182d
Cleared Jan 20, 2012
LIAISON 25 OH VITAMIN D TOTAL ASSAY
K112725 · MRG
Chemistry · 122d
Cleared Dec 14, 2009
LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
K093498 · JJX
Chemistry · 32d
Cleared Sep 09, 2009
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
K090104 · JJX
Chemistry · 237d
Cleared Oct 01, 2007
LIAISON 25 OH VITAMIN D TOTAL
K071480 · MRG
Chemistry · 125d
Cleared Jul 14, 2004
TSH-CTK-3 IRMA
K041014 · JLW
Chemistry · 85d
Cleared Feb 12, 2004
LIAISON 25 OH VITAMIN D
K032844 · MRG
Chemistry · 154d
Cleared Feb 12, 2004
LIAISON N-TACT PTH
K033426 · CEW
Chemistry · 108d
Cleared Mar 26, 2002
1,25-DIHYDROXYVITAMIN D125I RIA
K014030 · MRG
Chemistry · 110d
Cleared Apr 25, 2000
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K001118 · DFC
Chemistry · 18d
Cleared Nov 17, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K993669 · DFC
Chemistry · 16d
Cleared Apr 02, 1999
SPQ TEST SYSTEM
K982708 · DFC
Chemistry · 241d
Cleared Nov 16, 1998
25-HYDROXYVITAMIN D 125I RIA KIT
K983617 · LCI
Chemistry · 32d
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