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FDA 510(k)

RIA TSH IN HUMAN SERUM OR PLASMA

K-Number: K781150 · 1978-07-27

ApplicantDiagnostic Corp. of America
Decision Date1978-07-27
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA TSH IN HUMAN SERUM OR PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Corp. of America. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K781150. 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 RIA TSH IN HUMAN SERUM OR PLASMA?

RIA TSH IN HUMAN SERUM OR PLASMA is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Diagnostic Corp. of America. The 510(k) number is K781150.

When did RIA TSH IN HUMAN SERUM OR PLASMA receive FDA 510(k) clearance?

RIA TSH IN HUMAN SERUM OR PLASMA received FDA 510(k) clearance on 1978-07-27, under 510(k) number K781150.

Who is the listed applicant for RIA TSH IN HUMAN SERUM OR PLASMA?

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

What is the FDA product code for RIA TSH IN HUMAN SERUM OR PLASMA?

The FDA product code for RIA TSH IN HUMAN SERUM OR PLASMA is JLW.

Related Clinical Trials

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.

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Other records listing Diagnostic Corp. of America 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.

K810477DCA DIGOX-SYN RIA TESTK780412TOTAL IRON BINDING CAPACITY

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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