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)

QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

K-Number: K000733 · 2001-05-21

ApplicantInova Diagnostics, Inc.
Decision Date2001-05-21
Product CodeNBT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-05-21 under 510(k) number K000733. The device is classified under product code NBT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA?

QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA is a medical device that received FDA 510(k) clearance on 2001-05-21. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K000733.

When did QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA receive FDA 510(k) clearance?

QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA received FDA 510(k) clearance on 2001-05-21, under 510(k) number K000733.

Who is the listed applicant for QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA?

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

What is the FDA product code for QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA?

The FDA product code for QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA is NBT.

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 Inova 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.

K243979Aptiva APS IgA ReagentK223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentK213403Aptiva CTD Essential ReagentK200230Aptiva Celiac Disease IgG ReagentK193604Aptiva Celiac Disease IgA ReagentK192916NOVA Lite DAPI dsDNA Crithidia luciliae Kit

View all 127 devices →

Related Devices (Code: NBT)

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.

K071711ASCA-CHEKTechlab Inc., Corporate Research CenterK051927TECHLAB ASCA-CHEKTechlab, Inc.K051492AESKULISA ASCA AAesku, Inc.K042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITThe Binding SiteK032860IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)Immco Diagnostics, Inc.K032850IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)Immco Diagnostics, 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.

↑