Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

FDA product code JIL · 79 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1340
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-03-16 – 2023-04-13

JIL 2023-04-13

AUTION MAX AX-4060 Urinalysis System

Applicant Arkray, Inc.

K number K193514

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JIL 2019-05-07

cobas u 601 urinalysis test system

Applicant Roche Diagnostics

K number K183432

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JIL 2018-07-18

DIP/U.S. Urine Analysis Test System

Applicant Healthy.Io, Ltd.

K number K173327

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JIL 2018-05-25

inui In-Home Urine Analysis Test System

Applicant Scanadu, Inc.

K number K180356

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JIL 2018-05-23

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

Applicant DFI Co., Ltd.

K number K181024

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JIL 2018-02-16

DUS R-50S (Urine Chemistry system)

Applicant DFI Co., Ltd.

K number K171521

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JIL 2017-05-12

iChemVELOCITY Automated Urine Chemistry System

Applicant Iris Diagnostics, A Division of Iris International, Inc.

K number K171083

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JIL 2016-10-07

AUTION ELEVEN Semi-Automated Urinalysis System

Applicant Arkray, Inc.

K number K160062

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JIL 2016-07-22

URITEK TC-201 URINE CHEMISTRY TEST SYSTEM

Applicant Teco Diagnostics, Inc.

K number K160372

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JIL 2012-03-06

FORESIGHT U120 URINE ANALYZER

Applicant ACON Laboratories, Inc.

K number K120124

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JIL 2011-02-04

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10

Applicant Teco Diagnostics

K number K101673

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JIL 2009-10-09

CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797

Applicant Siemens Healthcare Diagnostics

K number K091216

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JIL 2007-04-06

COMBI SCAN100

Applicant Analyticon Biotechnologies AG

K number K061846

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JIL 2007-04-06

COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005

Applicant Analyticon Biotechnologies AG

K number K061812

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JIL 2007-03-01

URINE CHEMISTRY ANALYZER UR-50

Applicant Ind Diagnostic, Inc.

K number K063390

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JIL 2006-12-28

CLINITEK ADVANTUS, MODEL 1420

Applicant Bayer Healthcare, LLC

K number K063276

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JIL 2006-09-06

URYXXON RELAX URINE ANALYZER

Applicant Macherey-Nagel GmbH & Co. KG

K number K061742

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JIL 2006-06-13

ICHEM 100 URINE CHEMISTRY ANALYZER

Applicant Iris International, Inc.

K number K060280

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JIL 2006-03-29

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS

Applicant DFI Co., Ltd.

K number K052525

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JIL 2005-11-22

URYXXON 200 URINE ANALYZER

Applicant Macherey-Nagel GmbH & Co. KG

K number K051034

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JIL 2005-04-20

URISCAN OPTIMA II URINE ANALYZER

Applicant Yd Diagnostics

K number K050801

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JIL 2005-01-07

CHEMVIEW-10

Applicant Cenogenics Corp.

K number K042641

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JIL 2004-03-02

DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)

Applicant Hypoguard USA, Inc.

K number K033851

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JIL 2003-10-21

COMBI-SCREEN, MODELS 10SL AND 11SL

Applicant Analyticon Biotechnologies AG

K number K023885

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JIL 2003-10-08

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

Applicant Roche Diagnostics Corp.

K number K032437

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JIL 2002-09-17

POCKETCHEM UA AUTION STICKS 10TA

Applicant Arkray, Inc.

K number K022386

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JIL 2002-03-21

URS-IG (GLUCOSE TEST)

Applicant Teco Diagnostics

K number K020175

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JIL 2001-09-26

URISYS 2400 URINE TEST STRIP

Applicant Roche Diagnostics Corp.

K number K012397

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JIL 2001-09-11

DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000

Applicant Hypoguard USA, Inc.

K number K010973

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JIL 1999-09-17

MEDI-TEST COMBI 11

Applicant Macherey-Nagel-Duren

K number K991927

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JIL 1997-10-20

DBEST REAGENT STRIP FOR URINALYSIS

Applicant Ameritek, Inc.

K number K973142

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JIL 1997-04-08

CLINISTRIP

Applicant Teco Diagnostics

K number K970250

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JIL 1996-07-26

HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

Applicant Tcpi, Inc.

K number K954968

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JIL 1996-06-18

DIA SCREEN 10 WAY REAGENT STRIPS

Applicant Genesis Labs, Inc.

K number K961375

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JIL 1996-06-14

FIRST CHOICE GLUCOSE URINE TEST STRIPS

Applicant Polymer Technology Intl.

K number K953661

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JIL 1995-09-05

BIOSCAN

Applicant Biosys Laboratories, Inc.

K number K952307

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JIL 1995-08-11

DIA SCREEN REAGENT STRIPS

Applicant Genesis Labs, Inc.

K number K952971

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JIL 1995-03-24

IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET

Applicant Teco Diagnostics

K number K942648

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JIL 1995-03-21

URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD

Applicant Chemtech Labs, Inc.

K number K946116

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JIL 1994-09-09

URINE REAGENT STRIP-3 PARAMETERS

Applicant Teco Diagnostics

K number K940469

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JIL 1994-04-12

BIOSCAN REAGENT STRIPS

Applicant Bioscan Instruments, Inc.

K number K940043

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JIL 1994-01-13

UROPAPER EIKEN 6B

Applicant Tanabe U.S.A., Inc.

K number K932368

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JIL 1993-11-26

UROPAPER EIKEN HAG

Applicant Tanabe U.S.A., Inc.

K number K932366

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JIL 1993-11-26

UROPAPER EIKEN AG

Applicant Tanabe U.S.A., Inc.

K number K932365

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JIL 1993-11-16

UROPAPER EIKEN 7

Applicant Tanabe U.S.A., Inc.

K number K932369

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JIL 1993-11-16

UROPAPER EIKEN 8

Applicant Tanabe U.S.A., Inc.

K number K932367

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JIL 1993-11-16

UROPAPER EIKEN GP

Applicant Tanabe U.S.A., Inc.

K number K932364

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JIL 1993-11-16

UROPAPER EIKEN GK

Applicant Tanabe U.S.A., Inc.

K number K932363

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JIL 1993-11-16

UROPAPER

Applicant Tanabe U.S.A., Inc.

K number K931897

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JIL 1990-01-11

CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS

Applicant Boehringer Mannheim Corp.

K number K896454

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JIL 1990-01-10

CHARISE CHARLES REAGENT STRIPS

Applicant Lee Import Domestic Consulting

K number K895282

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JIL 1987-07-27

DIABETES RISK DETECTOR

Applicant Pearce Clinical Laboratories, Inc.

K number K864544

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JIL 1987-03-06

MAJOR QUALITY GLUCOSE AND KETONES URINE TEST

Applicant American Diagnostic Corp.

K number K870500

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JIL 1986-10-03

BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS

Applicant Behring Diagnostics, Inc.

K number K861255

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JIL 1986-07-25

ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS

Applicant Kyoto Diagnostics, Inc.

K number K861733

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JIL 1986-06-13

BIOTEL (TM)/ DIABETES

Applicant American Diagnostic Corp.

K number K855239

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JIL 1984-12-18

UROPAPER EIKEN G

Applicant Syn-Kit, Inc.

K number K843760

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JIL 1984-12-18

UROPAPER EIKEN HAG

Applicant Syn-Kit, Inc.

K number K843759

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JIL 1984-12-18

UROPAPER EIKEN GK

Applicant Syn-Kit, Inc.

K number K843758

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JIL 1984-12-18

UROPAPER EIKEN AG

Applicant Syn-Kit, Inc.

K number K843757

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JIL 1984-12-18

UROPAPER EIKEN 5

Applicant Syn-Kit, Inc.

K number K843756

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JIL 1984-12-18

UROPAPER EIKEN 6B

Applicant Syn-Kit, Inc.

K number K843755

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JIL 1984-12-18

UROPAPER EIKEN 7

Applicant Syn-Kit, Inc.

K number K843754

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JIL 1984-12-18

UROPAPER EIKEN GP

Applicant Syn-Kit, Inc.

K number K843753

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JIL 1984-05-31

KYOTEST 2V, URINE TEST REAGENT STRIP

Applicant Kyoto Diagnostics, Inc.

K number K841714

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JIL 1984-05-31

KYOTEST UG URINE TEST REAGENT STRIP

Applicant Kyoto Diagnostics, Inc.

K number K841713

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JIL 1984-05-14

YD STRIP GPH U21

Applicant Yd Pharmaceutical Corp.

K number K834387

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JIL 1984-05-14

YD STRIP GP U20

Applicant Yd Pharmaceutical Corp.

K number K834386

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JIL 1984-05-11

YD STRIP GLUCOSE U19

Applicant Yd Pharmaceutical Corp.

K number K834385

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JIL 1984-04-19

KYOTEST UGK

Applicant Kyoto Diagnostics, Inc.

K number K840829

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JIL 1983-09-08

DIASTIX REAGENT STRIPS FOR URINALYSIS

Applicant Miles Laboratories, Inc.

K number K831600

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JIL 1983-06-22

URI-TEST 3, INLAB REAGENT STRIPS-URINAL

Applicant Laprol Scientific, Inc.

K number K831498

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JIL 1982-05-05

BIOSTRIP G

Applicant Helena Laboratories

K number K820594

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JIL 1981-12-08

UROPAPER EIKEN UHAG

Applicant Syn-Kit, Inc.

K number K811816

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JIL 1981-07-23

UROPAPER EIKEN UAG

Applicant Syn-Kit, Inc.

K number K811818

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JIL 1981-07-15

UROPAPER EIKEN AG

Applicant Syn-Kit, Inc.

K number K811817

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JIL 1977-10-25

9-WAY URINE TEST WITH ASCORBIC

Applicant Miles Laboratories, Inc.

K number K771755

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JIL 1977-03-21

MEGA-DIASTIX

Applicant Miles Laboratories, Inc.

K number K761310

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JIL 1977-03-16

CHEMSTRIP G

Applicant Boehringer Mannheim Corp.

K number K770271

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