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FDA 510(k)

COLORSLIDER RUBELLA

K-Number: K952544 · 1996-01-17

ApplicantSeradyn, Inc.
Decision Date1996-01-17
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COLORSLIDER RUBELLA is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1996-01-17 under 510(k) number K952544. 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 COLORSLIDER RUBELLA?

COLORSLIDER RUBELLA is a medical device that received FDA 510(k) clearance on 1996-01-17. The listed applicant is Seradyn, Inc.. The 510(k) number is K952544.

When did COLORSLIDER RUBELLA receive FDA 510(k) clearance?

COLORSLIDER RUBELLA received FDA 510(k) clearance on 1996-01-17, under 510(k) number K952544.

Who is the listed applicant for COLORSLIDER RUBELLA?

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

What is the FDA product code for COLORSLIDER RUBELLA?

The FDA product code for COLORSLIDER RUBELLA is LQN.

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Other records listing Seradyn, 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.

K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

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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.

K031490RUBELLACOLImmunostics Inc.,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.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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