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FDA 510(k)

TSH RIA KIT

K-Number: K791217 · 1979-09-04

ApplicantAntibodies, Inc.
Decision Date1979-09-04
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 Antibodies, Inc.. It received FDA 510(k) clearance on 1979-09-04 under 510(k) number K791217. 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 1979-09-04. The listed applicant is Antibodies, Inc.. The 510(k) number is K791217.

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

TSH RIA KIT received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791217.

Who is the listed applicant for TSH RIA KIT?

The FDA 510(k) record lists Antibodies, Inc. 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 Antibodies, 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.

K890774GIARDEIA(TM)K843590DETECT-A-STREPK822892CORTISOL RIA KITK812749ULTRA-DIGK812314CRITHIDNA ANTI-DNA TEST KITK802877AMIKACIN 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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