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FDA 510(k)

AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA

K-Number: K992440 · 1999-09-21

ApplicantCogent Diagnotics , Ltd.
Decision Date1999-09-21
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Diagnotics , Ltd.. It received FDA 510(k) clearance on 1999-09-21 under 510(k) number K992440. 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 AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA?

AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA is a medical device that received FDA 510(k) clearance on 1999-09-21. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K992440.

When did AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA receive FDA 510(k) clearance?

AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA received FDA 510(k) clearance on 1999-09-21, under 510(k) number K992440.

Who is the listed applicant for AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA?

The FDA 510(k) record lists Cogent Diagnotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA?

The FDA product code for AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA is MID.

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Other records listing Cogent Diagnotics , 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.

K003057AUTOSTAT II ENA-4 PROFILE ELISAK003054AUTOSTAT II ENA-6 PROFILE ELISAK002215AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISAK993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISAK994338AUTOSTAT II RHEUMATOID FACTOR IGM ELISAK993085AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA

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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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