Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SIA THYROID STIMULATING HORMONE ELISA KIT

K-Number: K930050 · 1993-08-19

ApplicantSigma Chemical Co.
Decision Date1993-08-19
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIA THYROID STIMULATING HORMONE ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1993-08-19 under 510(k) number K930050. 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 SIA THYROID STIMULATING HORMONE ELISA KIT?

SIA THYROID STIMULATING HORMONE ELISA KIT is a medical device that received FDA 510(k) clearance on 1993-08-19. The listed applicant is Sigma Chemical Co.. The 510(k) number is K930050.

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

SIA THYROID STIMULATING HORMONE ELISA KIT received FDA 510(k) clearance on 1993-08-19, under 510(k) number K930050.

Who is the listed applicant for SIA THYROID STIMULATING HORMONE ELISA KIT?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIA THYROID STIMULATING HORMONE ELISA KIT?

The FDA product code for SIA THYROID STIMULATING HORMONE ELISA KIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sigma Chemical 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

View all 231 devices →

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.

↑