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FDA 510(k)

INNOFLUOR PHENOBARBITAL ASSAY SYSTEM

K-Number: K972330 · 1997-07-14

ApplicantOxis Intl., Inc.
Decision Date1997-07-14
Product CodeLGQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR PHENOBARBITAL 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 1997-07-14 under 510(k) number K972330. The device is classified under product code LGQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR PHENOBARBITAL ASSAY SYSTEM?

INNOFLUOR PHENOBARBITAL ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-14. The listed applicant is Oxis Intl., Inc.. The 510(k) number is K972330.

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

INNOFLUOR PHENOBARBITAL ASSAY SYSTEM received FDA 510(k) clearance on 1997-07-14, under 510(k) number K972330.

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

The FDA product code for INNOFLUOR PHENOBARBITAL ASSAY SYSTEM is LGQ.

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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 SYSTEMK970510INNOFLOUR TOPIRAMATE REAGENT SETK970517INNOFLUOR TOPIRAMATE CONTROL SETK970509INNOFLOUR CALIBRATOR REAGENT SETK955568INNOFLUOR QUINIDINE ASSAY SYSTEMK955569INNOFLUOR GENTAMICIN ASSAY SYSTEM

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Related Devices (Code: LGQ)

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 SYSTEMOxis Intl., Inc.K940596AXSYM PHENOBARBITALAbbott LaboratoriesK936130COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORSRoche Diagnostic Systems, Inc.K900704MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRAInnotron of Oregon, Inc.K894525FPR PHENOBARBITAL KITColony Laboratories, Inc.K872397COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.Roche 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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