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510(k) K023928

Device
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
510(k) number
K023928
Product code
JJW  
Decision
Substantially Equivalent (SESE)
Decision date
2002-12-11
Date received
2002-11-25
Regulation
862.1660
Classification name
Urinalysis Controls (assayed And Unassayed)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PENNY M LAYMAN
Address
5300 Adolfo Rd. Camarillo CA US 93012 93012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K022085J&S MEDICAL SENTRY URINE DIPSTICK CONTROLJ & S Medical Assoc., Inc.2002-07-25
K021155MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROLMedical Analysis Systems, Inc.2002-04-29

Legacy Summary#

summary

FDA Review#

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