FDA 510(k)

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

K-Number: K063131 · 2007-10-05

Decision Date2007-10-05

Product CodeKLT

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Electron OY. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K063131. 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 CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS?

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Thermo Electron OY. The 510(k) number is K063131.

When did CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS receive FDA 510(k) clearance?

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS received FDA 510(k) clearance on 2007-10-05, under 510(k) number K063131.

Who is the listed applicant for CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS?

The FDA 510(k) record lists Thermo Electron OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS?

The FDA product code for CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS is KLT.

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Other records listing Thermo Electron OY as applicant

K063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS K063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL K063838LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH K063086TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS K063209HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

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Related Devices (Code: KLT)

K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics Corporation K103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott Laboratories K042808ADVIA IMS CARBAMAZEPINE METHODBayer Healthcare, LLC K031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.K010814EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229Syva Co., Dade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.