510(k) K843824

Device: Cobas Fp Reagents For Phenytoin & Calibr
Applicant: ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number: K843824
Product code: LGR
Decision: Substantially Equivalent (SESE)
Decision date: 1985-02-01
Date received: 1984-09-28
Regulation: 862.3350
Classification name: Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Medical specialty: Clinical Toxicology
Review panel: Clinical Toxicology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

510(k) summary PDF not indicated by FDA

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K955873	ACS PHENYTOIN ASSAY	Ciba Corning Diagnostics Corp.	1996-03-11
K955562	INNOFLUOR PHENYTOIN ASSAY SYSTEM	Oxis Intl., Inc.	1996-01-24
K953840	AXSYM PHENYTOIN II	Abbott Laboratories	1995-09-25
K946328	TDX(R)/TDXFLX(R) PHENYTOIN II	Abbott Laboratories	1995-03-28
K943313	PHENYTOIN FPIA REAGENT SET AND CALIBRATORS	Sigma Diagnostics, Inc.	1994-10-27
K935375	AXSYM PHENYTOIN ASSAY	Abbott Laboratories	1994-06-21
K936131	COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS	Roche Diagnostic Systems, Inc.	1994-03-11
K896868	OPUS PHENYTOIN TEST SYSTEM	Pb Diagnostic Systems, Inc.	1990-01-02
K895827	INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET	Innotron of Oregon, Inc.	1989-10-31
K872563	INNOTRON INNOFLUOR PHEYTOIN REAGENT SET	Innotron of Oregon, Inc.	1987-08-21
K862554	IMMPULSE PHENYTOIN ASSAY REAGENT	Sclavo, Inc.	1986-07-16
K844171	PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1984-12-10
K842586	PHENYTOIN KIT FLUORESCENCE POLARIZATION	Windsor Laboratories, Inc.	1984-09-26
K841706	INNOFLUOR PHENYTOIN	Innotron Diagnostics	1984-05-22