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FDA 510(k)

SERADYN QMS TOPIRAMATE

K-Number: K070645 · 2007-05-17

ApplicantSeradyn, Inc.
Decision Date2007-05-17
Product CodeNWM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SERADYN QMS TOPIRAMATE is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 2007-05-17 under 510(k) number K070645. 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 SERADYN QMS TOPIRAMATE?

SERADYN QMS TOPIRAMATE is a medical device that received FDA 510(k) clearance on 2007-05-17. The listed applicant is Seradyn, Inc.. The 510(k) number is K070645.

When did SERADYN QMS TOPIRAMATE receive FDA 510(k) clearance?

SERADYN QMS TOPIRAMATE received FDA 510(k) clearance on 2007-05-17, under 510(k) number K070645.

Who is the listed applicant for SERADYN QMS TOPIRAMATE?

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 SERADYN QMS TOPIRAMATE?

The FDA product code for SERADYN QMS TOPIRAMATE 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.

K062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSK051211QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

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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.K051211QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLSSeradyn, 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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