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FDA 510(k)

RUBELLACOL

K-Number: K031490 · 2003-07-16

ApplicantImmunostics Inc.,
Decision Date2003-07-16
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLACOL is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2003-07-16 under 510(k) number K031490. 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 RUBELLACOL?

RUBELLACOL is a medical device that received FDA 510(k) clearance on 2003-07-16. The listed applicant is Immunostics Inc.,. The 510(k) number is K031490.

When did RUBELLACOL receive FDA 510(k) clearance?

RUBELLACOL received FDA 510(k) clearance on 2003-07-16, under 510(k) number K031490.

Who is the listed applicant for RUBELLACOL?

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

What is the FDA product code for RUBELLACOL?

The FDA product code for RUBELLACOL is LQN.

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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.

K970931COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.K954920MUREX RUB-EXMurex Diagnostics, Inc.K952544COLORSLIDER RUBELLASeradyn, Inc.K912391RUBALEX, MODIFICATIONOrion Corp.K901637RESUBMITTED MODIFIED RUBALEXOrion Corp.

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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