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FDA 510(k)

CARDIOLIPIN IGM EIA TEST SYSTEM

K-Number: K952521 · 1996-02-09

ApplicantImmunoprobe, Inc.
Decision Date1996-02-09
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CARDIOLIPIN IGM EIA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Immunoprobe, Inc.. It received FDA 510(k) clearance on 1996-02-09 under 510(k) number K952521. 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 CARDIOLIPIN IGM EIA TEST SYSTEM?

CARDIOLIPIN IGM EIA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Immunoprobe, Inc.. The 510(k) number is K952521.

When did CARDIOLIPIN IGM EIA TEST SYSTEM receive FDA 510(k) clearance?

CARDIOLIPIN IGM EIA TEST SYSTEM received FDA 510(k) clearance on 1996-02-09, under 510(k) number K952521.

Who is the listed applicant for CARDIOLIPIN IGM EIA TEST SYSTEM?

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

What is the FDA product code for CARDIOLIPIN IGM EIA TEST SYSTEM?

The FDA product code for CARDIOLIPIN IGM EIA TEST SYSTEM is MID.

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Other records listing Immunoprobe, 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.

K972406ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEMK971393MYCOPLASMA IGG ELISA TEST SYSTEMK961764PR-3 ELISA TEST SYSTEMK961765MPO ELISA TEST SYSTEMK951549EBNA IGG EIA TEST SYSTEMK952523CARDIOLIPIN IGG EIA TEST KIT

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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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