FDA.reportPublic FDA data

510(k) K850058

Device
Du Pont Tobramycin Assay Reagents
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
510(k) number
K850058
Product code
LCR
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-18
Date received
1985-01-08
Regulation
862.3900
Classification name
Fluorescent Immunoassay, Tobramycin
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROGER C BRIDEN
Address
Medical Products Dept. Barley Mill Plz., P22-1170 Wilmington DE US 19898 19898

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060998QMS TOBRAMYCINSeradyn, Inc.2006-07-21
K974029ACS TOBRAMYCINChiron Diagnostics Corp.1998-02-12
K962818TOBRAMYCIN FLEX REAGENT CARTRIDGEDade Intl., Inc.1996-09-13
K952568BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENTBeckman Instruments, Inc.1995-08-08
K911940OPUS(R) TOBRAMYCINPb Diagnostic Systems, Inc.1991-07-01
K911613VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4Exmoor Plastics , Ltd.1991-06-28
K854873INTRAOCULAR PRESSURE REDUCERMira, Inc.1986-02-04
K840847IMMPULSE TOBRAMYCIN ASSAY REAGENTSParagon Diagnostics, Inc.1984-04-04
K832408STRATUS TOBRAMYCIN FLUOROMETRIC ENZYMAmerican Dade1983-08-26
K822197NEEDLE HOLDERSKelleher Corp.1982-08-16
K821542VIRGO IMMUNO-PRECIPITATION ASSAY TOBRAElectro-Nucleonics Laboratories, Inc.1982-06-03
K820130ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAYSyva Co.1982-02-05
K813542TOBRAMYCIN FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.1982-01-12
K810941AMES TDA TOBRAMYCIN TESTMiles Laboratories, Inc.1981-04-17
K802668CYBREX TOBRAMYCINAbbott Laboratories1980-11-24