FDA 510(k)

ADVIA CENTAUR TSH3-ULTRA METHOD

K-Number: K083844 · 2009-05-08

Decision Date2009-05-08

Product CodeJLW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR TSH3-ULTRA METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K083844. 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 ADVIA CENTAUR TSH3-ULTRA METHOD?

ADVIA CENTAUR TSH3-ULTRA METHOD is a medical device that received FDA 510(k) clearance on 2009-05-08. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K083844.

When did ADVIA CENTAUR TSH3-ULTRA METHOD receive FDA 510(k) clearance?

ADVIA CENTAUR TSH3-ULTRA METHOD received FDA 510(k) clearance on 2009-05-08, under 510(k) number K083844.

Who is the listed applicant for ADVIA CENTAUR TSH3-ULTRA METHOD?

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

What is the FDA product code for ADVIA CENTAUR TSH3-ULTRA METHOD?

The FDA product code for ADVIA CENTAUR TSH3-ULTRA METHOD is JLW.

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Other records listing Siemens Healthcare Diagnostics as applicant

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Related Devices (Code: JLW)

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare Diagnostics K234091Maverick 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.

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.