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FDA 510(k)

A-GENT CARBAMAZEPINE

K-Number: K832631 · 1983-09-12

ApplicantAbbott Laboratories
Decision Date1983-09-12
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

A-GENT CARBAMAZEPINE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832631. 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 A-GENT CARBAMAZEPINE?

A-GENT CARBAMAZEPINE is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Abbott Laboratories. The 510(k) number is K832631.

When did A-GENT CARBAMAZEPINE receive FDA 510(k) clearance?

A-GENT CARBAMAZEPINE received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832631.

Who is the listed applicant for A-GENT CARBAMAZEPINE?

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 A-GENT CARBAMAZEPINE?

The FDA product code for A-GENT CARBAMAZEPINE is KLT.

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Other records listing Abbott Laboratories as applicant

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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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