# Siemens Medical Solutions Diagnostics

- Location (FDA's records): Tarrytown, NY
- FDA decisions: 12 (2007–2011): 11 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Siemens Medical Solutions Diagnostics (11); Siemens Medical Solutions Diagnostics Limited (1)
- Product codes: LCP (2), DHB (2), MTG (1), DCN (1), JFY (1), MKW (1), LTK (1), JIX (1), MQM (1), NQD (1)
- Predicates its devices cite: 21 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diagnostic Products Corp.: 9 (https://510kreport.com/company/diagnostic-products)
- Bayer Corp.: 3 (https://510kreport.com/company/bayer)
- Randox Laboratories, Ltd.: 2 (https://510kreport.com/company/randox-laboratories)
- Tosoh Medics, Inc.: 1 (https://510kreport.com/company/tosoh-medics)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Diagnostic Chemicals, Ltd.: 1 (https://510kreport.com/company/diagnostic-chemicals)
- Heraeus Kulzer, Inc.: 1 (https://510kreport.com/company/heraeus-kulzer)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 5 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Roche Diagnostics Operations: 1 (https://510kreport.com/company/roche-diagnostics-operations)
- Taidoc Technology Corporation: 1 (https://510kreport.com/company/taidoc-technology)
- Sakae Corporation: 1 (https://510kreport.com/company/sakae)
- Infopia Co, Ltd.: 1 (https://510kreport.com/company/infopia)
- Alfa Wassermann Diagnostic Technologies, Inc.: 1 (https://510kreport.com/company/alfa-wassermann-diagnostic-technologies)

## Its most-cited devices
- K071466: Dca Vantage, Model 5075 (2007), cited by 5
- K070727: Advia Chemistry Enzymatic Creatinine_2 (2007), cited by 2
- K081895: Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators (2009), cited by 1
- K100910: Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 (2011), cited by 1
- K073537: Neonatal Bilirubin on Rapidlab Models 1245 and 1265 (2008), cited by 1

## Recent decisions
- K100910: Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 (May 11, 2011)
- K091984: Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 (Oct 28, 2009)
- K081895: Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators (Jan 8, 2009)
- K071455: Advia Centaur Cyclosporine Assay and Calibrator (Sep 11, 2008)
- K073537: Neonatal Bilirubin on Rapidlab Models 1245 and 1265 (Jun 27, 2008)
- K072658: Advia Chemistry C-Reactive Protein_2, (CRP_2) and Calibrators (Apr 1, 2008)
- K072794: Immulite 2500 OM-MA, Model L5KOP (Nov 5, 2007)
- K071466: Dca Vantage, Model 5075 (Oct 9, 2007)

Source page: https://510kreport.com/company/siemens-medical-solutions-diagnostics