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)

THYROCHEK ONE-STEP RAPID TSH ASSAY

K-Number: K960195 · 1996-04-15

ApplicantFranklin Diagnostics, Inc.
Decision Date1996-04-15
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROCHEK ONE-STEP RAPID TSH ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Franklin Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K960195. 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 THYROCHEK ONE-STEP RAPID TSH ASSAY?

THYROCHEK ONE-STEP RAPID TSH ASSAY is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Franklin Diagnostics, Inc.. The 510(k) number is K960195.

When did THYROCHEK ONE-STEP RAPID TSH ASSAY receive FDA 510(k) clearance?

THYROCHEK ONE-STEP RAPID TSH ASSAY received FDA 510(k) clearance on 1996-04-15, under 510(k) number K960195.

Who is the listed applicant for THYROCHEK ONE-STEP RAPID TSH ASSAY?

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

What is the FDA product code for THYROCHEK ONE-STEP RAPID TSH ASSAY?

The FDA product code for THYROCHEK ONE-STEP RAPID TSH ASSAY 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 Franklin Diagnostics, 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.

K884612FRANKLIN COLLECTOR(R)

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.

↑