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510(k) K822241

Device
Folate/b12 Duo-bead Radioassay
Applicant
ABBOTT LABORATORIES
510(k) number
K822241
Product code
CEN
Decision
Substantially Equivalent (SESE)
Decision date
1982-10-26
Date received
1982-07-27
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
One Abbott Park Rd. Abbott Park IL US 60064 60064

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
K840827KYOTEST 5VKyoto Diagnostics, Inc.1984-05-14
K830824URINE SCREENING KITSyn-Kit, Inc.1983-06-12
K830979HELENA BIOSTRIP PHHelena Laboratories1983-05-05
K830091LITH A TEST TMLenal Creative Approaches, Inc.1983-02-15