Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
152
Total
151
Cleared
1
Denied
152 devices
Cleared
Jan 24, 2014
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
Chemistry
49d
Cleared
Jan 14, 2014
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
Immunology
133d
Cleared
Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
Chemistry
56d
Cleared
Oct 30, 2013
IMMULITE 2000
Immunology
30d
Cleared
Oct 25, 2013
IMMULITE 2000
Chemistry
25d
Cleared
Oct 22, 2013
IMMULITE 2000
Chemistry
22d
Cleared
Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP...
Chemistry
50d
Cleared
Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
Chemistry
125d
Cleared
Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
Chemistry
56d
Cleared
Aug 12, 2013
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
Immunology
75d
Cleared
Apr 04, 2013
IMMULITE 2000 ANTI-CCP IGG ASSAY
Immunology
309d
Cleared
Mar 22, 2013
DIMENSION EXL WITH LM SYSTEM
Chemistry
45d
Cleared
Mar 14, 2013
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
Immunology
206d
Cleared
Mar 14, 2013
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
Microbiology
84d
Cleared
Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
Chemistry
83d
Cleared
Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA...
Chemistry
147d
Cleared
Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
Chemistry
66d
Cleared
Oct 03, 2012
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
Chemistry
37d
Cleared
May 15, 2012
ADVIA CHEMISTRY GLUH_3 REAGENTS
Chemistry
70d
Cleared
May 09, 2012
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
Chemistry
29d
Cleared
Jan 20, 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
Immunology
297d
Cleared
Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
Microbiology
158d
Cleared
Jan 06, 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
Immunology
128d
Cleared
Dec 30, 2011
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
Chemistry
44d
Cleared
Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
Chemistry
227d
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