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FDA 510(k)

MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM

K-Number: K950829 · 1996-06-05

ApplicantMardx Diagnostics, Inc.
Decision Date1996-06-05
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MARDX LYME DISEASE (IGG) MARBLOT STRIP 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 1996-06-05 under 510(k) number K950829. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM?

MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-05. The listed applicant is Mardx Diagnostics, Inc.. The 510(k) number is K950829.

When did MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM receive FDA 510(k) clearance?

MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM received FDA 510(k) clearance on 1996-06-05, under 510(k) number K950829.

Who is the listed applicant for MARDX LYME DISEASE (IGG) MARBLOT STRIP 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 MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM?

The FDA product code for MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM is LSR.

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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 SYSTEMK960182DSDNA IMMUNOGLOBULIN EIA TEST SYSTEMK894293MARDX LYME DISEASE EIA (IGM) TEST SYSTEMK894224MARDX LYME DISEASE EIA (IGG) TEST SYSTEMK892206MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM

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Related Devices (Code: LSR)

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.

K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus ScientificK220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG

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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