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FDA 510(k)

INNOFLUOR TOPIRAMATE CONTROL SET

K-Number: K970517 · 1997-05-12

ApplicantOxis Intl., Inc.
Decision Date1997-05-12
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR TOPIRAMATE CONTROL SET 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 1997-05-12 under 510(k) number K970517. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR TOPIRAMATE CONTROL SET?

INNOFLUOR TOPIRAMATE CONTROL SET is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Oxis Intl., Inc.. The 510(k) number is K970517.

When did INNOFLUOR TOPIRAMATE CONTROL SET receive FDA 510(k) clearance?

INNOFLUOR TOPIRAMATE CONTROL SET received FDA 510(k) clearance on 1997-05-12, under 510(k) number K970517.

Who is the listed applicant for INNOFLUOR TOPIRAMATE CONTROL SET?

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 TOPIRAMATE CONTROL SET?

The FDA product code for INNOFLUOR TOPIRAMATE CONTROL SET is LAS.

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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 SETK955568INNOFLUOR QUINIDINE ASSAY SYSTEMK955569INNOFLUOR GENTAMICIN ASSAY SYSTEM

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Related Devices (Code: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.

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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