Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Atellica® IM TSH3-Ultra II (TSH3ULII)

K-Number: K251543 · 2026-02-06

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2026-02-06
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica® IM TSH3-Ultra II (TSH3ULII) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-02-06 under approval number K251543. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica® IM TSH3-Ultra II (TSH3ULII)?

Atellica® IM TSH3-Ultra II (TSH3ULII) is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K251543.

When was Atellica® IM TSH3-Ultra II (TSH3ULII) approved by the FDA?

Atellica® IM TSH3-Ultra II (TSH3ULII) received FDA 510(k) clearance on 2026-02-06, under approval number K251543.

What company makes Atellica® IM TSH3-Ultra II (TSH3ULII)?

Atellica® IM TSH3-Ultra II (TSH3ULII) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica® IM TSH3-Ultra II (TSH3ULII)?

The FDA product code for Atellica® IM TSH3-Ultra II (TSH3ULII) is JLW.

Other Devices by Siemens Healthcare Diagnostics, Inc.

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) K161964ADVIA Centaur HAV IgM Assay K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

View all 71 devices →

Related Devices (Code: JLW)

K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlSysmex America, Inc. K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc. K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc. K171103Lumipulse G TSH-III Immunoreaction CartridgesFujirebio Diagnostics,Inc. K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑