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510(k) K842366

Device
OXALATE URINE CONTROLS NORMAL & ELEVAT
Applicant
SIGMA CHEMICAL CO.
510(k) number
K842366
Product code
JJW  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-12
Date received
1984-06-15
Regulation
862.1660
Classification name
Urinalysis Controls (assayed And Unassayed)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
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 JJW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170091UA-Cellular CompleteStreck2017-02-09
K142262AUTION CHECK PLUSQuantimetrix Corp.2015-04-10
K131444UA-CELLULAR COMPLETEStreck2014-01-29
K110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories Limited2011-09-30
K103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.2011-02-02
K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa Corporation2009-01-16
K072640IRISPEC,CA/CB/CCIris Diagnostics2007-12-21
K070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.2007-04-25
K052242ADVIA CHEMISTRY MICROALBUMIN CONTROLSBayer Healthcare, LLC2005-10-03
K043266RANDOX URINE CONTROLSRandox Laboratories, Ltd.2005-02-15
K042446QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLSBio-Rad Laboratories, Inc.2004-11-02
K031441URICHEMTRAK LIQUID ASSAYED URINE CONTROLMedical Analysis Systems, Inc.2003-07-01
K031231LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSISBio-Rad2003-06-18
K023928MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROLMedical Analysis Systems, Inc.2002-12-11
K022085J&S MEDICAL SENTRY URINE DIPSTICK CONTROLJ & S Medical Assoc., Inc.2002-07-25

Legacy Summary#

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FDA Review#

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