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FDA 510(k)

INNOFLUOR CARBAMAZEPINE REAGENT SET

K-Number: K893507 · 1989-08-11

ApplicantInnotron of Oregon, Inc.
Decision Date1989-08-11
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR CARBAMAZEPINE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Innotron of Oregon, Inc.. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K893507. 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 INNOFLUOR CARBAMAZEPINE REAGENT SET?

INNOFLUOR CARBAMAZEPINE REAGENT SET is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K893507.

When did INNOFLUOR CARBAMAZEPINE REAGENT SET receive FDA 510(k) clearance?

INNOFLUOR CARBAMAZEPINE REAGENT SET received FDA 510(k) clearance on 1989-08-11, under 510(k) number K893507.

Who is the listed applicant for INNOFLUOR CARBAMAZEPINE REAGENT SET?

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

What is the FDA product code for INNOFLUOR CARBAMAZEPINE REAGENT SET?

The FDA product code for INNOFLUOR CARBAMAZEPINE REAGENT SET is KLT.

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Other records listing Innotron of Oregon, 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.

K903101INNOFLUOR (TM) AMIKACIN CALIBRATOR SETK903100INNOFLUOR (TM) AMIKACIN REAGENT SETK900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORK900708MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATORK900706MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAK900703MODIFIED ACCUFLUOR GENTAMICIN REAGENT & 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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