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FDA 510(k)

TSH RIASSAY

K-Number: K801691 · 1980-08-27

ApplicantRia Diagnostics
Decision Date1980-08-27
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH RIASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ria Diagnostics. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801691. 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 RIASSAY?

TSH RIASSAY is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Ria Diagnostics. The 510(k) number is K801691.

When did TSH RIASSAY receive FDA 510(k) clearance?

TSH RIASSAY received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801691.

Who is the listed applicant for TSH RIASSAY?

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

What is the FDA product code for TSH RIASSAY?

The FDA product code for TSH RIASSAY is JLW.

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Other records listing Ria Diagnostics 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.

K855033T-3 UPTAKE/RIASSAYK854798T-4 RIASSAYK852537T-3 RIASSAYK810296DIGOXIN RIA ASSAYK792062THEOPHYLLINE RIASSAYK780012ANTITHROMBIN III RIA

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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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