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FDA 510(k)

MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY

K-Number: K042281 · 2004-09-16

ApplicantBeckman Coulter, Inc.
Decision Date2004-09-16
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2004-09-16 under 510(k) number K042281. 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 MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY?

MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K042281.

When did MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY receive FDA 510(k) clearance?

MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY received FDA 510(k) clearance on 2004-09-16, under 510(k) number K042281.

Who is the listed applicant for MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY?

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

What is the FDA product code for MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY?

The FDA product code for MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY is JLW.

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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.

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 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.

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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