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 REBELLA IGG

K-Number: K971304 · 1998-01-02

ApplicantInova Diagnostics, Inc.
Decision Date1998-01-02
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE REBELLA IGG 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 1998-01-02 under 510(k) number K971304. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE REBELLA IGG?

QUANTA LITE REBELLA IGG is a medical device that received FDA 510(k) clearance on 1998-01-02. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K971304.

When did QUANTA LITE REBELLA IGG receive FDA 510(k) clearance?

QUANTA LITE REBELLA IGG received FDA 510(k) clearance on 1998-01-02, under 510(k) number K971304.

Who is the listed applicant for QUANTA LITE REBELLA IGG?

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 REBELLA IGG?

The FDA product code for QUANTA LITE REBELLA IGG is LFX.

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: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

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.

↑