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FDA 510(k)

INNOFLUOR PHENYTOIN ASSAY SYSTEM

K-Number: K955562 · 1996-01-24

ApplicantOxis Intl., Inc.
Decision Date1996-01-24
Product CodeLGR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR PHENYTOIN ASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oxis Intl., Inc.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K955562. 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 ASSAY SYSTEM?

INNOFLUOR PHENYTOIN ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Oxis Intl., Inc.. The 510(k) number is K955562.

When did INNOFLUOR PHENYTOIN ASSAY SYSTEM receive FDA 510(k) clearance?

INNOFLUOR PHENYTOIN ASSAY SYSTEM received FDA 510(k) clearance on 1996-01-24, under 510(k) number K955562.

Who is the listed applicant for INNOFLUOR PHENYTOIN ASSAY SYSTEM?

The FDA 510(k) record lists Oxis Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOFLUOR PHENYTOIN ASSAY SYSTEM?

The FDA product code for INNOFLUOR PHENYTOIN ASSAY SYSTEM is LGR.

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Other records listing Oxis Intl., 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.

K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMK972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMK970510INNOFLOUR TOPIRAMATE REAGENT SETK970509INNOFLOUR CALIBRATOR REAGENT SETK970517INNOFLUOR TOPIRAMATE CONTROL SETK955568INNOFLUOR QUINIDINE ASSAY SYSTEM

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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.K953840AXSYM PHENYTOIN IIAbbott LaboratoriesK946328TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott LaboratoriesK943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K935375AXSYM PHENYTOIN ASSAYAbbott LaboratoriesK936131COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORSRoche Diagnostic Systems, 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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