Medical Device Manufacturer · US , New York , NY

Siemens Medical Solutions Diagnostics

11 submissions · 11 cleared · Since 2007
11
Total
11
Cleared
0
Denied

Siemens Medical Solutions Diagnostics — FDA 510(k) Submissions

Siemens Medical Solutions Diagnostics has submitted 11 FDA 510(k) premarket notifications since 2007, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Glycosylated Hemoglobin, System, Test, Radioallergosorbent (rast) Immunological, Enzymatic Method, Creatinine, Cardiac C-reactive Protein, Antigen, Antiserum, And Control, Cyclosporine . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
K100910 · DHB System, Test,... · Immunology
May 2011 405d
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
K091984 · DHB System, Test,... · Immunology
Oct 2009 118d
ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
K081895 · LCP Assay, Glycosylated... · Chemistry
Jan 2009 189d
ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
K071455 · MKW Cyclosporine · Toxicology
Sep 2008 475d
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
K073537 · MQM Bilirubin (total And... · Chemistry
Jun 2008 193d
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
K072658 · DCN System, Test, C-reactive... · Immunology
Apr 2008 194d
IMMULITE 2500 OM-MA, MODEL L5KOP
K072794 · LTK Test, Epithelial Ovarian... · Immunology
Nov 2007 35d
DCA VANTAGE, MODEL 5075
K071466 · LCP Assay, Glycosylated... · Chemistry
Oct 2007 133d
ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
K072204 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 2007 58d
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
K070727 · JFY Enzymatic Method, Creatinine · Chemistry
Aug 2007 141d
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
K071017 · NQD Cardiac C-reactive... · Chemistry
May 2007 22d
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