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FDA 510(k)

BIOTRACK CARBAMAZEPINE TEST CARTRIDGE

K-Number: K915756 · 1992-07-23

ApplicantBiotrack, Inc.
Decision Date1992-07-23
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOTRACK CARBAMAZEPINE TEST CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1992-07-23 under 510(k) number K915756. 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 BIOTRACK CARBAMAZEPINE TEST CARTRIDGE?

BIOTRACK CARBAMAZEPINE TEST CARTRIDGE is a medical device that received FDA 510(k) clearance on 1992-07-23. The listed applicant is Biotrack, Inc.. The 510(k) number is K915756.

When did BIOTRACK CARBAMAZEPINE TEST CARTRIDGE receive FDA 510(k) clearance?

BIOTRACK CARBAMAZEPINE TEST CARTRIDGE received FDA 510(k) clearance on 1992-07-23, under 510(k) number K915756.

Who is the listed applicant for BIOTRACK CARBAMAZEPINE TEST CARTRIDGE?

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

What is the FDA product code for BIOTRACK CARBAMAZEPINE TEST CARTRIDGE?

The FDA product code for BIOTRACK CARBAMAZEPINE TEST CARTRIDGE is KLT.

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Other records listing Biotrack, Inc. 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.

K934061BIOTRACK VALPROIC ACID TEST CARTRIDGEK934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLSK920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLK915755BIOTRACK PHENYTOIN TEST CARTRIDGEK903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSK900373BIOTRACK THEOPHYLLINE TEST CARTRIDGE

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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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