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FDA 510(k)

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

K-Number: K051211 · 2005-11-18

ApplicantSeradyn, Inc.
Decision Date2005-11-18
Product CodeNWM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 2005-11-18 under 510(k) number K051211. The device is classified under product code NWM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS?

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS is a medical device that received FDA 510(k) clearance on 2005-11-18. The listed applicant is Seradyn, Inc.. The 510(k) number is K051211.

When did QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS receive FDA 510(k) clearance?

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS received FDA 510(k) clearance on 2005-11-18, under 510(k) number K051211.

Who is the listed applicant for QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS?

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 ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS?

The FDA product code for QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS is NWM.

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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: NWM)

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.

K201089ARK Lacosamide AssayArk Diagnostics, Inc.K091884ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003Ark Diagnostics, Inc.K083799TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00Ark Diagnostics, Inc.K070645SERADYN QMS TOPIRAMATESeradyn, 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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