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FDA 510(k)

MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR

K-Number: K900707 · 1990-04-20

ApplicantInnotron of Oregon, Inc.
Decision Date1990-04-20
Product CodeLFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR 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 1990-04-20 under 510(k) number K900707. The device is classified under product code LFW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR?

MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR is a medical device that received FDA 510(k) clearance on 1990-04-20. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K900707.

When did MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR receive FDA 510(k) clearance?

MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR received FDA 510(k) clearance on 1990-04-20, under 510(k) number K900707.

Who is the listed applicant for MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR?

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 MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR?

The FDA product code for MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR is LFW.

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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 SETK900708MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATORK900706MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAK900703MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATORK900705MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR

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Related Devices (Code: LFW)

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.

K964670ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.K944371TOBRAMYCIN FPIA REAGENT SET AND CALIBRATORSigma Diagnostics, Inc.K941614AXSYM TOBRAMYCINAbbott LaboratoriesK912143CEDIA(R) TOBRAMYCIN ASSAYMicrogenics Corp.K894531FPR TOBRAMYCIN KITColony Laboratories, Inc.K872562INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SETInnotron of Oregon, 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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