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FDA 510(k)

QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

K-Number: K052826 · 2005-12-23

ApplicantSeradyn, Inc.
Decision Date2005-12-23
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS QUINIDINE. QMS QUINIDINE CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 2005-12-23 under 510(k) number K052826. The device is classified under product code LBZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS QUINIDINE. QMS QUINIDINE CALIBRATORS?

QMS QUINIDINE. QMS QUINIDINE CALIBRATORS is a medical device that received FDA 510(k) clearance on 2005-12-23. The listed applicant is Seradyn, Inc.. The 510(k) number is K052826.

When did QMS QUINIDINE. QMS QUINIDINE CALIBRATORS receive FDA 510(k) clearance?

QMS QUINIDINE. QMS QUINIDINE CALIBRATORS received FDA 510(k) clearance on 2005-12-23, under 510(k) number K052826.

Who is the listed applicant for QMS QUINIDINE. QMS QUINIDINE CALIBRATORS?

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 QMS QUINIDINE. QMS QUINIDINE CALIBRATORS?

The FDA product code for QMS QUINIDINE. QMS QUINIDINE CALIBRATORS is LBZ.

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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 GENTAMICINK051211QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

View all 28 devices →

Related Devices (Code: LBZ)

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.

K032332ROCHE ONLINE TDM QUINIDINERoche Diagnostics Corp.K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.K964116QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K964212QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K955568INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., Inc.K941440COBAS-FP QUINIDINE REAGENTS AND CALIBRATORSRoche Diagnostic Systems, 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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