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FDA 510(k)

THYROID STIMULATING HORMONE

K-Number: K822935 · 1982-11-01

ApplicantPcl-Ria, Inc.
Decision Date1982-11-01
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROID STIMULATING HORMONE is the device name listed in this FDA 510(k) record. The listed applicant is Pcl-Ria, Inc.. It received FDA 510(k) clearance on 1982-11-01 under 510(k) number K822935. 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 THYROID STIMULATING HORMONE?

THYROID STIMULATING HORMONE is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Pcl-Ria, Inc.. The 510(k) number is K822935.

When did THYROID STIMULATING HORMONE receive FDA 510(k) clearance?

THYROID STIMULATING HORMONE received FDA 510(k) clearance on 1982-11-01, under 510(k) number K822935.

Who is the listed applicant for THYROID STIMULATING HORMONE?

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

What is the FDA product code for THYROID STIMULATING HORMONE?

The FDA product code for THYROID STIMULATING HORMONE is JLW.

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Other records listing Pcl-Ria, Inc. 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.

K830526B-GCG SYSTEM BY RIAK823014DIGOXIN KITK822612T3 UPTAKE KITSK820886THYROXINE T4 KITK820358FOLLICLE STIMULATING HORMONE KITK820357LUTEINIZING HORMONE 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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