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 T3 ASSAY

K-Number: K934764 · 1994-03-22

ApplicantBiomerieux Vitek, Inc.
Decision Date1994-03-22
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIDAS T3 ASSAY 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 1994-03-22 under 510(k) number K934764. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS T3 ASSAY?

VIDAS T3 ASSAY is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K934764.

When did VIDAS T3 ASSAY receive FDA 510(k) clearance?

VIDAS T3 ASSAY received FDA 510(k) clearance on 1994-03-22, under 510(k) number K934764.

Who is the listed applicant for VIDAS T3 ASSAY?

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 T3 ASSAY?

The FDA product code for VIDAS T3 ASSAY is CDP.

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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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.

↑