510(k) K972331

Device: INNOFLUOR GENTAMICIN ASSAY SYSTEM
Applicant: OXIS INTL., INC.
510(k) number: K972331
Product code: LGQ
Decision: Substantially Equivalent (SESE)
Decision date: 1997-08-01
Date received: 1997-06-23
Regulation: 862.3660
Classification name: Fluorescence Polarization Immunoassay, Phenobarbital
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: LYNDA M TAYLOR
Address: 6040 N. Cutter Cir., #317 Portland OR US 97217 97217

FDA Registration Numbers#

3006198300
3003795116
9610126
9610529

Source Documents#

Other 510(k) Records For Product Code LGQ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K972330	INNOFLUOR PHENOBARBITAL ASSAY SYSTEM	Oxis Intl., Inc.	1997-07-14
K940596	AXSYM PHENOBARBITAL	Abbott Laboratories	1994-06-21
K936130	COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS	Roche Diagnostic Systems, Inc.	1994-03-11
K900704	MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA	Innotron of Oregon, Inc.	1990-04-12
K894525	FPR PHENOBARBITAL KIT	Colony Laboratories, Inc.	1989-08-28
K872397	COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.	Roche Diagnostic Systems, Inc.	1987-07-21
K863625	PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT	Windsor Laboratories, Inc.	1986-11-10
K862528	IMMPULSE PHENOBARBITAL ASSAY REAGENTS	Sclavo, Inc.	1986-07-16
K854044	TDX BARBITURATES	Abbott Laboratories	1985-10-28
K843825	COBAS REAGENTS PHENOBARBITAL & PHENOBAR	Roche Diagnostic Systems, Inc.	1985-02-01
K841707	INNOFLUOR PHENOBARBITAL	Innotron Diagnostics	1984-05-23

Legacy Summary#

summary

FDA Review#

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