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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K251543.

When did Atellica® IM TSH3-Ultra II (TSH3ULII) receive FDA 510(k) clearance?

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

Who is the listed applicant for Atellica® IM TSH3-Ultra II (TSH3ULII)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Siemens Healthcare Diagnostics, Inc. as applicant

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Related Devices (Code: JLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.K190773Elecsys TSHRoche Diagnostics

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.

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