510(k) Report

FDA applicant

Siemens Medical Solutions Diagnostics

Tarrytown, NY12 decisions2007–201116 recalls

FDA records 12 decisions for Siemens Medical Solutions Diagnostics (Tarrytown, NY) from 2007 to 2011: 11 510(k) clearances and 1 original PMA approval. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and DHB (System, Test, Radioallergosorbent (Rast)…). Its devices cite 21 predicates, 0 of them its own earlier devices. 16 recalls are linked to its devices.

FDA’s records also spell it “Siemens Medical Solutions Diagnostics Limited”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Siemens Medical Solutions Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 62008: 32009: 22011: 1
2007high 6 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

3in 2020

2012: 22013: 12014: 32015: 12016: 32018: 12019: 22020: 3
2007high 3 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Siemens Medical Solutions Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LCPAssay, Glycosylated Hemoglobin2decisions
  • DHBSystem, Test, Radioallergosorbent (Rast) Immunological2decisions
  • MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer…1decision
  • DCNSystem, Test, C-Reactive Protein1decision
  • JFYEnzymatic Method, Creatinine1decision
  • MKWCyclosporine1decision

Also: LTK (1), JIX (1), MQM (1), NQD (1).

Whose devices does it build on?

Its devices cite 21 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071466Dca Vantage, Model 5075Siemens Medical Solutions Diagnostics · 20075cite it
  • K070727Advia Chemistry Enzymatic Creatinine_2Siemens Medical Solutions Diagnostics · 20072cite it
  • K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 20091cites it
  • K100910Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics · 20111cites it
  • K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics · 20081cites it

What has FDA decided for it lately?

  • K100910Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics · 2011
  • K091984Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics · 2009
  • K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 20092 recalls
  • K071455Advia Centaur Cyclosporine Assay and CalibratorSiemens Medical Solutions Diagnostics · 20081 recall
  • K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics · 20087 recalls
  • K072658Advia Chemistry C-Reactive Protein_2, (CRP_2) and CalibratorsSiemens Medical Solutions Diagnostics · 2008
  • K072794Immulite 2500 OM-MA, Model L5KOPSiemens Medical Solutions Diagnostics · 2007
  • K071466Dca Vantage, Model 5075Siemens Medical Solutions Diagnostics · 20071 recall

All 11 as Siemens Medical Solutions Diagnostics →The one decision as Siemens Medical Solutions Diagnostics Limited →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K071466DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW…Jun 30, 2020Class II
  • K070727Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number…May 4, 2020Class II
  • K070727ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number…May 4, 2020Class II
  • K070727ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869Dec 18, 2019Class II
  • K070727Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533Dec 18, 2019Class II
  • K071455ADVIA Centaur¿ CyclosporineJan 2, 2018Class II