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FDA 510(k)

TERUMO SENSIBEAD EIA TSH KIT

K-Number: K850376 · 1985-03-04

ApplicantTerumo Medical Corp.
Decision Date1985-03-04
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TERUMO SENSIBEAD EIA TSH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1985-03-04 under 510(k) number K850376. 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 TERUMO SENSIBEAD EIA TSH KIT?

TERUMO SENSIBEAD EIA TSH KIT is a medical device that received FDA 510(k) clearance on 1985-03-04. The listed applicant is Terumo Medical Corp.. The 510(k) number is K850376.

When did TERUMO SENSIBEAD EIA TSH KIT receive FDA 510(k) clearance?

TERUMO SENSIBEAD EIA TSH KIT received FDA 510(k) clearance on 1985-03-04, under 510(k) number K850376.

Who is the listed applicant for TERUMO SENSIBEAD EIA TSH KIT?

The FDA 510(k) record lists Terumo Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO SENSIBEAD EIA TSH KIT?

The FDA product code for TERUMO SENSIBEAD EIA TSH KIT is JLW.

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Other records listing Terumo Medical Corp. 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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