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FDA 510(k)

INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET

K-Number: K895827 · 1989-10-31

ApplicantInnotron of Oregon, Inc.
Decision Date1989-10-31
Product CodeLGR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR PHENYTOIN MANUAL FPIA 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 1989-10-31 under 510(k) number K895827. The device is classified under product code LGR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET?

INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K895827.

When did INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET receive FDA 510(k) clearance?

INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895827.

Who is the listed applicant for INNOFLUOR PHENYTOIN MANUAL FPIA 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 PHENYTOIN MANUAL FPIA REAGENT SET?

The FDA product code for INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET is LGR.

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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: LGR)

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.

K955873ACS PHENYTOIN ASSAYCiba Corning Diagnostics Corp.K955562INNOFLUOR PHENYTOIN ASSAY SYSTEMOxis Intl., Inc.K953840AXSYM PHENYTOIN IIAbbott LaboratoriesK946328TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott LaboratoriesK943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K935375AXSYM PHENYTOIN ASSAYAbbott Laboratories

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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