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FDA 510(k)

MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR

K-Number: K900705 · 1990-04-12

ApplicantInnotron of Oregon, Inc.
Decision Date1990-04-12
Product CodeLBZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFIED ACCUFLUOR QUINIDINE 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 1990-04-12 under 510(k) number K900705. The device is classified under product code LBZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR?

MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR is a medical device that received FDA 510(k) clearance on 1990-04-12. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K900705.

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

MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR received FDA 510(k) clearance on 1990-04-12, under 510(k) number K900705.

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

The FDA product code for MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR is LBZ.

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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: LBZ)

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.

K052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSSeradyn, Inc.K032332ROCHE ONLINE TDM QUINIDINERoche Diagnostics Corp.K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.K964116QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K964212QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K955568INNOFLUOR QUINIDINE ASSAY SYSTEMOxis Intl., 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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