Medical Device Manufacturer · US , Portland , OR

Oxis Intl., Inc.

11 submissions · 11 cleared · Since 1995
11
Total
11
Cleared
0
Denied

Oxis Intl., Inc. — FDA 510(k) Submissions

Oxis Intl., Inc. has submitted 11 FDA 510(k) premarket notifications since 1995, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fluorescence Polarization Immunoassay, Phenobarbital, Discs, Strips And Reagents, Microorganism Differentiation, Fluorescence Polarization Immunoassay, Diphenylhydantoin (total), Fluorescence Polarization Immunoassay, Theophylline, Enzyme Immunoassay, Quinidine . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K972331 · LGQ Fluorescence Polarization... · Toxicology
Aug 1997 39d
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
K972330 · LGQ Fluorescence Polarization... · Toxicology
Jul 1997 21d
INNOFLOUR CALIBRATOR REAGENT SET
K970509 · DLJ Calibrators, Drug Specific · Toxicology
May 1997 90d
INNOFLOUR TOPIRAMATE REAGENT SET
K970510 · MSL System, Test, Topiramatee · Toxicology
May 1997 90d
INNOFLUOR TOPIRAMATE CONTROL SET
K970517 · LAS Drug Specific Control... · Toxicology
May 1997 90d
INNOFLUOR QUINIDINE ASSAY SYSTEM
K955568 · LBZ Enzyme Immunoassay,... · Toxicology
Apr 1996 120d
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K955569 · LCQ Fluorescent Immunoassay... · Toxicology
Feb 1996 65d
INNOFLUOR AMIKACIN ASSAY SYSTEM
K955570 · KLQ Radioimmunoassay, Amikacin · Toxicology
Feb 1996 65d
INNOFLUOR PHENYTOIN ASSAY SYSTEM
K955562 · LGR Fluorescence Polarization... · Toxicology
Jan 1996 49d
INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
K955567 · LGS Fluorescence Polarization... · Toxicology
Jan 1996 49d
B-L RED(TM) DISCS
K950346 · JTO Discs, Strips And... · Microbiology
May 1995 98d
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