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FDA 510(k)

CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT

K-Number: K834052 · 1984-01-24

ApplicantAbbott Laboratories
Decision Date1984-01-24
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1984-01-24 under 510(k) number K834052. 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 CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT?

CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1984-01-24. The listed applicant is Abbott Laboratories. The 510(k) number is K834052.

When did CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT receive FDA 510(k) clearance?

CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT received FDA 510(k) clearance on 1984-01-24, under 510(k) number K834052.

Who is the listed applicant for CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT?

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 CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT?

The FDA product code for CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT is KLT.

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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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