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FDA 510(k)

QMS CARBAMAZEPINE ASSAY

K-Number: K940374 · 1994-06-02

ApplicantSeradyn, Inc.
Decision Date1994-06-02
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS CARBAMAZEPINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K940374. The device is classified under product code KLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS CARBAMAZEPINE ASSAY?

QMS CARBAMAZEPINE ASSAY is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Seradyn, Inc.. The 510(k) number is K940374.

When did QMS CARBAMAZEPINE ASSAY receive FDA 510(k) clearance?

QMS CARBAMAZEPINE ASSAY received FDA 510(k) clearance on 1994-06-02, under 510(k) number K940374.

Who is the listed applicant for QMS CARBAMAZEPINE ASSAY?

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 CARBAMAZEPINE ASSAY?

The FDA product code for QMS CARBAMAZEPINE ASSAY is KLT.

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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: KLT)

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.

K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics CorporationK103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott LaboratoriesK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSThermo Electron OYK042808ADVIA IMS CARBAMAZEPINE METHODBayer Healthcare, LLCK031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.

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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