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FDA 510(k)

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM

K-Number: K960182 · 1996-03-20

ApplicantMardx Diagnostics, Inc.
Decision Date1996-03-20
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mardx Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-03-20 under 510(k) number K960182. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM?

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-20. The listed applicant is Mardx Diagnostics, Inc.. The 510(k) number is K960182.

When did DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM receive FDA 510(k) clearance?

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM received FDA 510(k) clearance on 1996-03-20, under 510(k) number K960182.

Who is the listed applicant for DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM?

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

What is the FDA product code for DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM?

The FDA product code for DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM is LRM.

Related Clinical Trials

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Other records listing Mardx Diagnostics, 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.

K964787MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEMK951709MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEMK950829MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEMK894293MARDX LYME DISEASE EIA (IGM) TEST SYSTEMK894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEMK892206MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM

View all 8 devices →

Related Devices (Code: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, Inc.

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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