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FDA 510(k)

INNOFLUOR (TM) AMIKACIN REAGENT SET

K-Number: K903100 · 1990-08-09

ApplicantInnotron of Oregon, Inc.
Decision Date1990-08-09
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR (TM) AMIKACIN 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 1990-08-09 under 510(k) number K903100. The device is classified under product code KLQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR (TM) AMIKACIN REAGENT SET?

INNOFLUOR (TM) AMIKACIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K903100.

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

INNOFLUOR (TM) AMIKACIN REAGENT SET received FDA 510(k) clearance on 1990-08-09, under 510(k) number K903100.

Who is the listed applicant for INNOFLUOR (TM) AMIKACIN 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 (TM) AMIKACIN REAGENT SET?

The FDA product code for INNOFLUOR (TM) AMIKACIN REAGENT SET is KLQ.

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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 SETK900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORK900708MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATORK900706MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAK900703MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATORK900705MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR

View all 28 devices →

Related Devices (Code: KLQ)

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.

K052815QMS AMIKACIN REAGENTSSeradyn, Inc.K033884RANDOX AMIKACINRandox Laboratories, Ltd.K955570INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.K894517FPR AMIKACIN KITColony Laboratories, Inc.K852317COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche Diagnostic Systems, Inc.K843211AMIKACIN ANALYTICAL TEST PACK ACAE.I. Dupont DE Nemours & Co., Inc.

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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