FDA.reportPublic FDA data

510(k) K832975

Device
Bacterueria Screening Procedure
Applicant
TURNER DESIGNS, INC.
510(k) number
K832975
Product code
JXA
Decision
Substantially Equivalent (SESE)
Decision date
1983-11-14
Date received
1983-09-01
Regulation
866.2660
Classification name
Kit, Screening, Urine
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JXA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)Osmetech2001-11-30
K981084URISCREENDiatech Diagnostics,Inc.1998-10-07
K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.1998-02-23
K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.1995-06-20
K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.1995-04-14
K950246MULTIPLE (IZON URINE COLLECTION KIT)Izon Business Products, Inc.1995-03-21
K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)Izon Business Products, Inc.1995-03-21
K934759CULTURIA MACCONKEY-MUGClinical Convenience Products, Inc.1994-09-09
K924218BAC-T-SCREENBiomerieux Vitek, Inc.1993-02-03
K921045DIASLIDE URINE CULTURING DEVICESavyon Diagnostics , Ltd.1992-09-28
K911846URI-THREE(TM), MODIFICATIONCulture Kits, Inc.1991-10-04
K903470QUALTUREFuture Medical Technologies Intl., Inc.1990-12-13
K894805RAPIDEC URDms Products, Inc.1989-09-26
K892216GEN-PROBE PACE SYSTEM URINE SCREENGen-Probe, Inc.1989-09-15
K882211URISCREENDiatech Diagnostica , Ltd.1988-09-30