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FDA 510(k)

ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM

K-Number: K981020 · 1998-05-18

ApplicantZeus Scientific, Inc.
Decision Date1998-05-18
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1998-05-18 under 510(k) number K981020. 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 ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM?

ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-18. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K981020.

When did ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM receive FDA 510(k) clearance?

ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM received FDA 510(k) clearance on 1998-05-18, under 510(k) number K981020.

Who is the listed applicant for ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM?

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

What is the FDA product code for ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM?

The FDA product code for ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM is MID.

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Other records listing Zeus Scientific, 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

View all 135 devices →

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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