# Siemens Healthcare Diagnostics, Inc.

- Location (FDA's records): Tarrytown, NY
- FDA decisions: 265 (1995–2026): 245 510(k) clearances, 1 De Novo grant and 19 original PMA approvals
- Names in FDA's records: Siemens Healthcare Diagnostics, Inc. (163); Siemens Healthcare Diagnostics (102)
- Product codes: JJX (34), JIX (12), JIT (11), JLW (10), DHB (9), LTT (6), MMI (6), SEI (5), CEC (5), CDZ (5), DJG (4), DAP (4)
- 510(k) review time since 2016: median 221 days, against 203 for FDA's reviews in the same codes and years (5 of 19 faster)
- Predicates its devices cite: 340 (84 its own); citations of its devices by later devices: 113 (84 its own)
- Recalls linked to its devices: 247 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dade Behring, Inc.: 69 (https://510kreport.com/company/dade-behring)
- Roche Diagnostics Corp.: 37 (https://510kreport.com/company/roche-diagnostics)
- Diagnostic Products Corp.: 24 (https://510kreport.com/company/diagnostic-products)
- Ciba Corning Diagnostics Corp.: 11 (https://510kreport.com/company/ciba-corning-diagnostics)
- Bayer Healthcare, LLC: 11 (https://510kreport.com/company/bayer-healthcare)
- Bayer Corp.: 8 (https://510kreport.com/company/bayer)
- E.I. Dupont DE Nemours & Co., Inc.: 7 (https://510kreport.com/company/ei-dupont-de-nemours)
- Beckman Coulter, Inc.: 7 (https://510kreport.com/company/beckman-coulter)

## Firms that cite its devices most
- Shenzhen New Industries Biomedical Engineering Co., Ltd.: 3 (https://510kreport.com/company/shenzhen-new-industries-biomedical-engineering)
- Beckman Coulter, Inc.: 3 (https://510kreport.com/company/beckman-coulter)
- Immunalysis Corporation: 2 (https://510kreport.com/company/immunalysis)
- Abbott Point of Care, Inc.: 2 (https://510kreport.com/company/abbott-point-of-care)
- Randox Laboratories, Ltd.: 2 (https://510kreport.com/company/randox-laboratories)
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Siemens Healthcare Diagnostic Products GmbH: 2 (https://510kreport.com/company/siemens-healthcare-diagnostic-products)
- Teco Diagnostics: 2 (https://510kreport.com/company/teco-diagnostics)

## Its most-cited devices
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), cited by 7
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), cited by 6
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (2009), cited by 4
- K083844: Advia Centaur TSH3-Ultra Method (2009), cited by 4
- K102904: Enhanced Estradiol (EE2) Master Curve Material (2010), cited by 3
- K151792: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System (2015), cited by 3

## Recent decisions
- K253528: Atellica IM CA 19-9 II (Aug 10, 2026)
- K261364: Atellica CH Acetaminophen 2 (ACTM) (Jul 24, 2026)
- P250026: Atellica IM free PSA II (fPSAII) (May 11, 2026)
- K251998: Atellica CH Diazo Total Bilirubin (D_TBil) (Feb 27, 2026)
- K251543: Atellica® IM TSH3-Ultra II (TSH3ULII) (Feb 6, 2026)
- K251630: Atellica IM Total PSA II (tPSAII) (Jan 5, 2026)
- K250816: ADVIA Centaur Anti-Thyroglobulin II (aTgII) (Dec 4, 2025)
- P240021: Atellica IM Total PSA II (tPSAII) (Dec 3, 2025)

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