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FDA 510(k)

DETERMINATION OF CARBAMAZEPINE

K-Number: K860047 · 1986-01-22

ApplicantClinical Data, Inc.
Decision Date1986-01-22
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DETERMINATION OF CARBAMAZEPINE is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 1986-01-22 under 510(k) number K860047. 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 DETERMINATION OF CARBAMAZEPINE?

DETERMINATION OF CARBAMAZEPINE is a medical device that received FDA 510(k) clearance on 1986-01-22. The listed applicant is Clinical Data, Inc.. The 510(k) number is K860047.

When did DETERMINATION OF CARBAMAZEPINE receive FDA 510(k) clearance?

DETERMINATION OF CARBAMAZEPINE received FDA 510(k) clearance on 1986-01-22, under 510(k) number K860047.

Who is the listed applicant for DETERMINATION OF CARBAMAZEPINE?

The FDA 510(k) record lists Clinical Data, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DETERMINATION OF CARBAMAZEPINE?

The FDA product code for DETERMINATION OF CARBAMAZEPINE is KLT.

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K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITK033983VITALAB IRON REAGENTK040631VITALAB DIRECT BILIRUBIN REAGENTK040534VITALAB AMYLASE REAGENTK034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB 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.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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