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FDA 510(k)

INNOFLOUR TOPIRAMATE REAGENT SET

K-Number: K970510 · 1997-05-12

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

Device Summary

INNOFLOUR TOPIRAMATE REAGENT 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 K970510. The device is classified under product code MSL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLOUR TOPIRAMATE REAGENT SET?

INNOFLOUR TOPIRAMATE REAGENT 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 K970510.

When did INNOFLOUR TOPIRAMATE REAGENT SET receive FDA 510(k) clearance?

INNOFLOUR TOPIRAMATE REAGENT SET received FDA 510(k) clearance on 1997-05-12, under 510(k) number K970510.

Who is the listed applicant for INNOFLOUR TOPIRAMATE REAGENT 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 INNOFLOUR TOPIRAMATE REAGENT SET?

The FDA product code for INNOFLOUR TOPIRAMATE REAGENT SET is MSL.

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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 SYSTEMK970517INNOFLUOR TOPIRAMATE CONTROL SETK970509INNOFLOUR CALIBRATOR REAGENT SETK955568INNOFLUOR QUINIDINE ASSAY SYSTEMK955569INNOFLUOR GENTAMICIN ASSAY SYSTEM

View all 11 devices →

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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