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FDA 510(k)

TSH RIA REAGENT SET

K-Number: K771234 · 1977-10-18

ApplicantG.D. Searle and Co.
Decision Date1977-10-18
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TSH RIA REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1977-10-18 under 510(k) number K771234. 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 REAGENT SET?

TSH RIA REAGENT SET is a medical device that received FDA 510(k) clearance on 1977-10-18. The listed applicant is G.D. Searle and Co.. The 510(k) number is K771234.

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

TSH RIA REAGENT SET received FDA 510(k) clearance on 1977-10-18, under 510(k) number K771234.

Who is the listed applicant for TSH RIA REAGENT SET?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSH RIA REAGENT SET?

The FDA product code for TSH RIA REAGENT SET is JLW.

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Other records listing G.D. Searle and Co. 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.

K821159IN-LINE OXYGEN MONITORING SYSTEMK811068BYPASS COILK811071VENOUS OXYGEN PROBEK803238INTRAVASCULAR CATHETERK810630SILICONE ELASTOMER COATED LATEX FOLEYK810131ADMINISTRATION SET

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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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