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FDA 510(k)

TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE

K-Number: K851148 · 1985-04-29

ApplicantEuro-Diagnostics BV
Decision Date1985-04-29
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Euro-Diagnostics BV. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K851148. 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 TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE?

TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Euro-Diagnostics BV. The 510(k) number is K851148.

When did TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE receive FDA 510(k) clearance?

TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851148.

Who is the listed applicant for TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE?

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

What is the FDA product code for TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE?

The FDA product code for TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE is JLW.

Related Clinical Trials

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.

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Other records listing Euro-Diagnostics BV 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.

K851332BLHI LUTEINIZING HORMONEK850053BACI 6 -ADRENOCORTICOTROOP HORMONEK843930IRMA IMMUNORADIOMETRIC ASSAY-FSH 125IK842478PROLACTIN IRMA

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

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

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