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 CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

K-Number: K905211 · 1991-10-11

ApplicantVitek Systems, Inc.
Decision Date1991-10-11
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K905211. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY?

VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K905211.

When did VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY receive FDA 510(k) clearance?

VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY received FDA 510(k) clearance on 1991-10-11, under 510(k) number K905211.

Who is the listed applicant for VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY?

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

What is the FDA product code for VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY?

The FDA product code for VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY is LLH.

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 Vitek Systems, 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.

K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK912371BIOMERIEUX RSV DIRECT IF KIT

View all 39 devices →

Related Devices (Code: LLH)

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.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, 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.

↑