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FDA 510(k)

RADIOIMMUNOASSAY FOR HUMAN THYROID

K-Number: K813392 · 1981-12-22

ApplicantLeeco Diagnostics, Inc.
Decision Date1981-12-22
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY FOR HUMAN THYROID is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-12-22 under 510(k) number K813392. 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 RADIOIMMUNOASSAY FOR HUMAN THYROID?

RADIOIMMUNOASSAY FOR HUMAN THYROID is a medical device that received FDA 510(k) clearance on 1981-12-22. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K813392.

When did RADIOIMMUNOASSAY FOR HUMAN THYROID receive FDA 510(k) clearance?

RADIOIMMUNOASSAY FOR HUMAN THYROID received FDA 510(k) clearance on 1981-12-22, under 510(k) number K813392.

Who is the listed applicant for RADIOIMMUNOASSAY FOR HUMAN THYROID?

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

What is the FDA product code for RADIOIMMUNOASSAY FOR HUMAN THYROID?

The FDA product code for RADIOIMMUNOASSAY FOR HUMAN THYROID is JLW.

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Other records listing Leeco Diagnostics, Inc. as applicant

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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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