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FDA 510(k)

TSH (RIA) KIT

K-Number: K820089 · 1982-01-28

ApplicantImmuno Assay Corp.
Decision Date1982-01-28
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH (RIA) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Assay Corp.. It received FDA 510(k) clearance on 1982-01-28 under 510(k) number K820089. 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 (RIA) KIT?

TSH (RIA) KIT is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is Immuno Assay Corp.. The 510(k) number is K820089.

When did TSH (RIA) KIT receive FDA 510(k) clearance?

TSH (RIA) KIT received FDA 510(k) clearance on 1982-01-28, under 510(k) number K820089.

Who is the listed applicant for TSH (RIA) KIT?

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

What is the FDA product code for TSH (RIA) KIT?

The FDA product code for TSH (RIA) KIT is JLW.

Other records listing Immuno Assay 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.

K833842RIA COAT DIGOXINK833745RIACOAT T-4K820074CORTISOL (RIA) KITK811954COMBO-FER IRON DIAGNOSTICK811725TBG DIAGNOSTIC KITK811213T3 (RIA) KIT

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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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