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)

VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT

K-Number: K931031 · 1993-07-27

ApplicantBiomerieux Vitek, Inc.
Decision Date1993-07-27
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K931031. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT?

VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K931031.

When did VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT receive FDA 510(k) clearance?

VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT received FDA 510(k) clearance on 1993-07-27, under 510(k) number K931031.

Who is the listed applicant for VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT?

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

What is the FDA product code for VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT?

The FDA product code for VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT is JFT.

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 Biomerieux Vitek, 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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

View all 49 devices →

Related Devices (Code: JFT)

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.

K242505Elecsys Cortisol IIIRoche DiagnosticsK192788ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc.K152227Elecsys Cortisol II, Cortisol II CalSetRoche DiagnosticsK062204ARCHITECT CORTISOL ASSAYSeradyn, Inc.K033731AXSYM CORTISOL ASSAYFujirebio Diagnostics,Inc.K021218ELECSYS CORTISOL TEST SYSTEMRoche Diagnostics Corp.

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.

↑