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FDA 510(k)

FPR CARBAMAZEPINE KIT

K-Number: K894519 · 1989-08-28

ApplicantColony Laboratories, Inc.
Decision Date1989-08-28
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FPR CARBAMAZEPINE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Colony Laboratories, Inc.. It received FDA 510(k) clearance on 1989-08-28 under 510(k) number K894519. 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 FPR CARBAMAZEPINE KIT?

FPR CARBAMAZEPINE KIT is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Colony Laboratories, Inc.. The 510(k) number is K894519.

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

FPR CARBAMAZEPINE KIT received FDA 510(k) clearance on 1989-08-28, under 510(k) number K894519.

Who is the listed applicant for FPR CARBAMAZEPINE KIT?

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

What is the FDA product code for FPR CARBAMAZEPINE KIT?

The FDA product code for FPR CARBAMAZEPINE KIT is KLT.

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Other records listing Colony Laboratories, 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.

K894524FPR GENTAMICIN CALIBRATOR KITK894517FPR AMIKACIN KITK894523FPR GENTAMICIN KITK894518FPR AMIKACIN CALIBRATOR KITK894527FPR PHENYTOIN KITK894521FPR DIGOXIN KIT

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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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