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FDA 510(k)

ELEGANCE NEONATAL TSH ELISA

K-Number: K935049 · 1994-10-03

ApplicantBioclone Australia Pty , Ltd.
Decision Date1994-10-03
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELEGANCE NEONATAL TSH ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Bioclone Australia Pty , Ltd.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K935049. 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 ELEGANCE NEONATAL TSH ELISA?

ELEGANCE NEONATAL TSH ELISA is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Bioclone Australia Pty , Ltd.. The 510(k) number is K935049.

When did ELEGANCE NEONATAL TSH ELISA receive FDA 510(k) clearance?

ELEGANCE NEONATAL TSH ELISA received FDA 510(k) clearance on 1994-10-03, under 510(k) number K935049.

Who is the listed applicant for ELEGANCE NEONATAL TSH ELISA?

The FDA 510(k) record lists Bioclone Australia Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEGANCE NEONATAL TSH ELISA?

The FDA product code for ELEGANCE NEONATAL TSH ELISA is JLW.

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Other records listing Bioclone Australia Pty , Ltd. as applicant

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.

K922284ELEGANCE FT4 ELISAK910419BIOCLONE'S ELEGANCE IGE ELISA KITK910420BIOCLONE'S ELEGANCE HCG ELISA KITK905099ELEGANCE TSH ELISAK905098ELEGANCE GH ELISAK904822ELEGANCE FERRITIN ELISA

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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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