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FDA 510(k)

HEMAGEN ANTI CARDIOLIPIN SCREEN

K-Number: K971039 · 1997-06-03

ApplicantHemagen Diagnostics, Inc.
Decision Date1997-06-03
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEMAGEN ANTI CARDIOLIPIN SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-06-03 under 510(k) number K971039. 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 HEMAGEN ANTI CARDIOLIPIN SCREEN?

HEMAGEN ANTI CARDIOLIPIN SCREEN is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K971039.

When did HEMAGEN ANTI CARDIOLIPIN SCREEN receive FDA 510(k) clearance?

HEMAGEN ANTI CARDIOLIPIN SCREEN received FDA 510(k) clearance on 1997-06-03, under 510(k) number K971039.

Who is the listed applicant for HEMAGEN ANTI CARDIOLIPIN SCREEN?

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

What is the FDA product code for HEMAGEN ANTI CARDIOLIPIN SCREEN?

The FDA product code for HEMAGEN ANTI CARDIOLIPIN SCREEN is MID.

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Other records listing Hemagen Diagnostics, Inc. as applicant

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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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