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FDA 510(k)

ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY

K-Number: K962926 · 1996-10-10

ApplicantAmerican Laboratory Products Co., Ltd.
Decision Date1996-10-10
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Laboratory Products Co., Ltd.. It received FDA 510(k) clearance on 1996-10-10 under 510(k) number K962926. 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 ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY?

ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY is a medical device that received FDA 510(k) clearance on 1996-10-10. The listed applicant is American Laboratory Products Co., Ltd.. The 510(k) number is K962926.

When did ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY receive FDA 510(k) clearance?

ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY received FDA 510(k) clearance on 1996-10-10, under 510(k) number K962926.

Who is the listed applicant for ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY?

The FDA 510(k) record lists American Laboratory Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY?

The FDA product code for ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY is MID.

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Other records listing American Laboratory Products Co., Ltd. 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.

K012576CIC-C1Q EIAK011415ALPCO MILENIA ANTI-TG EIAK011201ALPCO MILENIA ANTI-TPO ELISAK974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAK974701ORGENTEC ANTI-MPO (P-ANCA) ELISAK972190THYROGLOBULIN ASSAY SYSTEM

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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

View on FDA Database →

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

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