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FDA 510(k)

ONLINE TDM CARBAMAZEPINE

K-Number: K031902 · 2003-09-17

ApplicantRoche Diagnostics Corp.
Decision Date2003-09-17
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE TDM CARBAMAZEPINE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-09-17 under 510(k) number K031902. 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 ONLINE TDM CARBAMAZEPINE?

ONLINE TDM CARBAMAZEPINE is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K031902.

When did ONLINE TDM CARBAMAZEPINE receive FDA 510(k) clearance?

ONLINE TDM CARBAMAZEPINE received FDA 510(k) clearance on 2003-09-17, under 510(k) number K031902.

Who is the listed applicant for ONLINE TDM CARBAMAZEPINE?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONLINE TDM CARBAMAZEPINE?

The FDA product code for ONLINE TDM CARBAMAZEPINE is KLT.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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, LLCK011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.K010814EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229Syva Co., Dade Behring, 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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