Automated Urinalysis System
FDA product code KQO · 43 cleared devices
Class 1
Clinical Chemistry
- Regulation
- 21 CFR 862.2900
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-10-29 – 2013-02-01
KQO
2013-02-01
KQO
2011-08-09
CYBOW READER, MODELS 300 & 720
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KQO
2011-03-23
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
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KQO
2010-04-27
URITEST 50 AND URITEST 500 URINE ANALYZER
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KQO
2010-04-02
COBAS U411 TEST SYSTEM
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KQO
2009-12-23
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
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KQO
2007-07-30
ACON U120 URINE ANALYZER, MODEL U111-101
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KQO
2006-02-17
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
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KQO
2005-08-16
URITEK-720+ URINE ANALYZER
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KQO
2005-05-09
URITEK 151 URINE ANALYZER, MODEL TC-151
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KQO
2003-12-19
BAYER CLINITEK STATUS ANALYZER
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KQO
2003-07-11
AUTION JET AJ-4270 URINE ANALYZER
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KQO
2002-01-18
AUTION MAX AX-4280 URINALYSIS SYSTEM
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KQO
2001-11-02
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
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KQO
1998-10-27
CHEMSTRIP 101 URINE ANALYZER
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KQO
1998-06-10
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
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KQO
1997-08-25
THE YELLOW IRIS URINALYSIS WORKSTATION
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KQO
1996-07-22
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
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KQO
1996-06-21
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
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KQO
1996-06-12
CLINITEK 50 URINE CHEMISTRY ANALYZER
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KQO
1996-05-14
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
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KQO
1996-04-30
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
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KQO
1996-03-22
900UDX URINE PATHOLOGY SYSTEM
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KQO
1995-10-23
CHEMSTRIP CRITERION URINE ANALYZER
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KQO
1995-02-22
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
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KQO
1994-11-08
CHEMSTRIP MINI UA URINE ANALYZER
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KQO
1994-09-20
THE YELLOW IRIS
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KQO
1994-06-13
UA PERFECT
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KQO
1993-10-14
CHEMSTRIP SUPER UA URINE ANALYZER
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KQO
1993-08-19
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM
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KQO
1993-06-15
CHEMSTRIP URINE ANALYZER
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KQO
1993-01-28
CLINITEK 200+ URINE CHEMISTRY ANALYZER
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KQO
1992-03-24
CHEMSTRIP URINE ANALYZER
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KQO
1987-03-06
SUPER URINE ANALYZER SYSTEM
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KQO
1984-08-24
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
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KQO
1984-08-15
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
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KQO
1984-07-25
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
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KQO
1984-05-01
URINE ANALYZER SYSTEM
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KQO
1983-06-17
YELLOW IRIS TM
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KQO
1982-07-06
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
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KQO
1982-05-05
AUTOMATED URINALYSIS SYSTEM
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KQO
1977-03-21
CLINILAB AUTOMATED URINALYSIS SYSTEM
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KQO
1976-10-29
INSTRUMENTED SYSTEM FOR URINALYSIS
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