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FDA 510(k)

CARDIOLIPIN G EIA TEST SYSTEM

K-Number: K946215 · 1996-01-24

ApplicantHogan & Hartson
Decision Date1996-01-24
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CARDIOLIPIN G EIA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hogan & Hartson. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K946215. 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 G EIA TEST SYSTEM?

CARDIOLIPIN G EIA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Hogan & Hartson. The 510(k) number is K946215.

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

CARDIOLIPIN G EIA TEST SYSTEM received FDA 510(k) clearance on 1996-01-24, under 510(k) number K946215.

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

The FDA 510(k) record lists Hogan & Hartson as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Hogan & Hartson 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.

K974168COOPERSURGICAL INFRARED COAGULATORK973849BIOABSORBABLE BANKART TACKK973162DUAL RADIATION TARGETING SYSTEM DRTS DRAPEK950169RIBOSOMAL P EIA TEST SYSTEMK942389TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVESK946217CARDIOLIPIN M EIA TEST 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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