FDA 510(k)

AXSYM CARBAMAZEPHINE

K-Number: K935374 · 1994-06-21

Decision Date1994-06-21

Product CodeKLT

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

AXSYM CARBAMAZEPHINE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-06-21 under 510(k) number K935374. 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 AXSYM CARBAMAZEPHINE?

AXSYM CARBAMAZEPHINE is a medical device that received FDA 510(k) clearance on 1994-06-21. The listed applicant is Abbott Laboratories. The 510(k) number is K935374.

When did AXSYM CARBAMAZEPHINE receive FDA 510(k) clearance?

AXSYM CARBAMAZEPHINE received FDA 510(k) clearance on 1994-06-21, under 510(k) number K935374.

Who is the listed applicant for AXSYM CARBAMAZEPHINE?

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

What is the FDA product code for AXSYM CARBAMAZEPHINE?

The FDA product code for AXSYM CARBAMAZEPHINE is KLT.

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Related Devices (Code: KLT)

K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics Corporation K103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott Laboratories K063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSThermo Electron OY K042808ADVIA IMS CARBAMAZEPINE METHODBayer Healthcare, LLC K031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.

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.