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FDA 510(k)

APL IGA ELISA KIT

K-Number: K021398 · 2002-08-27

ApplicantLouisville Apl Diagnostics, Inc.
Decision Date2002-08-27
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

APL IGA ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Louisville Apl Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-08-27 under 510(k) number K021398. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APL IGA ELISA KIT?

APL IGA ELISA KIT is a medical device that received FDA 510(k) clearance on 2002-08-27. The listed applicant is Louisville Apl Diagnostics, Inc.. The 510(k) number is K021398.

When did APL IGA ELISA KIT receive FDA 510(k) clearance?

APL IGA ELISA KIT received FDA 510(k) clearance on 2002-08-27, under 510(k) number K021398.

Who is the listed applicant for APL IGA ELISA KIT?

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

What is the FDA product code for APL IGA ELISA KIT?

The FDA product code for APL IGA ELISA KIT is MID.

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 Louisville Apl 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.

K984102ACL/APS FACS KITK933588APHLELISA KIT

Related Devices (Code: MID)

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.

K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K130528BIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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