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510(k) K840827

Device
KYOTEST 5V
Applicant
KYOTO DIAGNOSTICS, INC.
510(k) number
K840827
Product code
CEN  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-14
Date received
1984-02-24
Regulation
862.1550
Classification name
Dye-indicator, Ph (urinary, Non-quantitative)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CEN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091287VS-SENSE TESTCommon Sense , Ltd.2009-08-31
K071100AMNISCREEN HOME DETECTION LINER KITCommon Sense , Ltd.2007-10-15
K051727AIMSTICK URINE REAGENT STRIPSGermaine Laboratories, Inc.2005-10-26
K040008QUICKVUE ADVANCE PH AND AMINES GLL TESTQuidel Corp.2004-04-29
K030650STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONSUridynamics, Inc.2003-04-14
K962718FEMEXAM TESTCARDLitmus Concepts, Inc.1997-02-07
K830824URINE SCREENING KITSyn-Kit, Inc.1983-06-12
K830979HELENA BIOSTRIP PHHelena Laboratories1983-05-05
K830091LITH A TEST TMLenal Creative Approaches, Inc.1983-02-15
K822241FOLATE/B12 DUO-BEAD RADIOASSAYAbbott Laboratories1982-10-26

Legacy Summary#

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FDA Review#

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