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FDA 510(k)

ACL/APS FACS KIT

K-Number: K984102 · 1999-03-18

ApplicantLouisville Apl Diagnostics, Inc.
Decision Date1999-03-18
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACL/APS FACS 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 1999-03-18 under 510(k) number K984102. 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 ACL/APS FACS KIT?

ACL/APS FACS KIT is a medical device that received FDA 510(k) clearance on 1999-03-18. The listed applicant is Louisville Apl Diagnostics, Inc.. The 510(k) number is K984102.

When did ACL/APS FACS KIT receive FDA 510(k) clearance?

ACL/APS FACS KIT received FDA 510(k) clearance on 1999-03-18, under 510(k) number K984102.

Who is the listed applicant for ACL/APS FACS 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 ACL/APS FACS KIT?

The FDA product code for ACL/APS FACS KIT is MID.

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.

K021398APL IGA ELISA 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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