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FDA 510(k)

MUREX RUB-EX

K-Number: K954920 · 1996-08-21

ApplicantMurex Diagnostics, Inc.
Decision Date1996-08-21
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MUREX RUB-EX is the device name listed in this FDA 510(k) record. The listed applicant is Murex Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-08-21 under 510(k) number K954920. The device is classified under product code LQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUREX RUB-EX?

MUREX RUB-EX is a medical device that received FDA 510(k) clearance on 1996-08-21. The listed applicant is Murex Diagnostics, Inc.. The 510(k) number is K954920.

When did MUREX RUB-EX receive FDA 510(k) clearance?

MUREX RUB-EX received FDA 510(k) clearance on 1996-08-21, under 510(k) number K954920.

Who is the listed applicant for MUREX RUB-EX?

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

What is the FDA product code for MUREX RUB-EX?

The FDA product code for MUREX RUB-EX is LQN.

Related Clinical Trials

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.

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Other records listing Murex 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.

K962028WELLCOLEX E-COLI OI57 ZC60

Related Devices (Code: LQN)

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.

K031490RUBELLACOLImmunostics Inc.,K970931COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.K952544COLORSLIDER RUBELLASeradyn, Inc.K912391RUBALEX, MODIFICATIONOrion Corp.K901637RESUBMITTED MODIFIED RUBALEXOrion Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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