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FDA 510(k)

RANDOX CARBAMAZEPINE

K-Number: K011648 · 2002-01-15

ApplicantRandox Laboratories, Ltd.
Decision Date2002-01-15
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX CARBAMAZEPINE is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2002-01-15 under 510(k) number K011648. 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 RANDOX CARBAMAZEPINE?

RANDOX CARBAMAZEPINE is a medical device that received FDA 510(k) clearance on 2002-01-15. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K011648.

When did RANDOX CARBAMAZEPINE receive FDA 510(k) clearance?

RANDOX CARBAMAZEPINE received FDA 510(k) clearance on 2002-01-15, under 510(k) number K011648.

Who is the listed applicant for RANDOX CARBAMAZEPINE?

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

What is the FDA product code for RANDOX CARBAMAZEPINE?

The FDA product code for RANDOX CARBAMAZEPINE is KLT.

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Other records listing Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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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.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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