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FDA 510(k)

INNOFLUOR THEOPHYLLINE ASSAY SYSTEM

K-Number: K955567 · 1996-01-24

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

Device Summary

INNOFLUOR THEOPHYLLINE 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 K955567. The device is classified under product code LGS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR THEOPHYLLINE ASSAY SYSTEM?

INNOFLUOR THEOPHYLLINE 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 K955567.

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

INNOFLUOR THEOPHYLLINE ASSAY SYSTEM received FDA 510(k) clearance on 1996-01-24, under 510(k) number K955567.

Who is the listed applicant for INNOFLUOR THEOPHYLLINE 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 THEOPHYLLINE ASSAY SYSTEM?

The FDA product code for INNOFLUOR THEOPHYLLINE ASSAY SYSTEM is LGS.

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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: LGS)

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.

K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.K953016AXSYM THEOPHYLLINE IIAbbott LaboratoriesK951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.K942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott LaboratoriesK922991ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINEAbbott 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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