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FDA 510(k)

INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET

K-Number: K872562 · 1987-08-17

ApplicantInnotron of Oregon, Inc.
Decision Date1987-08-17
Product CodeLFW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOTRON INNOFLUOR TOBRAMYCIN 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 1987-08-17 under 510(k) number K872562. 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 INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET?

INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1987-08-17. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K872562.

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

INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET received FDA 510(k) clearance on 1987-08-17, under 510(k) number K872562.

Who is the listed applicant for INNOTRON INNOFLUOR TOBRAMYCIN 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 INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET?

The FDA product code for INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET 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 SETK900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORK900708MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATORK900706MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAK900703MODIFIED ACCUFLUOR GENTAMICIN 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.K900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORInnotron of Oregon, Inc.K894531FPR TOBRAMYCIN KITColony Laboratories, 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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