| AUTION MAX AX-4060 Urinalysis System (K193514) | Arkray, Inc. | 2023-04-13 |
| cobas u 601 urinalysis test system (K183432) | Roche Diagnostics | 2019-05-07 |
| DIP/U.S. Urine Analysis Test System (K173327) | Healthy.Io, Ltd. | 2018-07-18 |
| inui In-Home Urine Analysis Test System (K180356) | Scanadu, Inc. | 2018-05-25 |
| DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (K181024) | DFI Co., Ltd. | 2018-05-23 |
| DUS R-50S (Urine Chemistry system) (K171521) | DFI Co., Ltd. | 2018-02-16 |
| iChemVELOCITY Automated Urine Chemistry System (K171083) | Iris Diagnostics, A Division of Iris International, Inc. | 2017-05-12 |
| AUTION ELEVEN Semi-Automated Urinalysis System (K160062) | Arkray, Inc. | 2016-10-07 |
| URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (K160372) | Teco Diagnostics, Inc. | 2016-07-22 |
| TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (K141289) | Teco Diagnostics | 2015-07-24 |
| URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (K131600) | Teco Diagnostics | 2014-05-29 |
| FORESIGHT U120 URINE ANALYZER (K120124) | ACON Laboratories, Inc. | 2012-03-06 |
| URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (K101673) | Teco Diagnostics | 2011-02-04 |
| CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 (K091216) | Siemens Healthcare Diagnostics | 2009-10-09 |
| COMBI SCAN100 (K061846) | Analyticon Biotechnologies AG | 2007-04-06 |
| COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 (K061812) | Analyticon Biotechnologies AG | 2007-04-06 |
| URINE CHEMISTRY ANALYZER UR-50 (K063390) | Ind Diagnostic, Inc. | 2007-03-01 |
| CLINITEK ADVANTUS, MODEL 1420 (K063276) | Bayer Healthcare, LLC | 2006-12-28 |
| URYXXON RELAX URINE ANALYZER (K061742) | Macherey-Nagel GmbH & Co. KG | 2006-09-06 |
| ICHEM 100 URINE CHEMISTRY ANALYZER (K060280) | Iris International, Inc. | 2006-06-13 |
| CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS (K052525) | DFI Co., Ltd. | 2006-03-29 |
| URYXXON 200 URINE ANALYZER (K051034) | Macherey-Nagel GmbH & Co. KG | 2005-11-22 |
| URISCAN OPTIMA II URINE ANALYZER (K050801) | Yd Diagnostics | 2005-04-20 |
| CHEMVIEW-10 (K042641) | Cenogenics Corp. | 2005-01-07 |
| DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) (K033851) | Hypoguard USA, Inc. | 2004-03-02 |
| COMBI-SCREEN, MODELS 10SL AND 11SL (K023885) | Analyticon Biotechnologies AG | 2003-10-21 |
| CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS (K032437) | Roche Diagnostics Corp. | 2003-10-08 |
| POCKETCHEM UA AUTION STICKS 10TA (K022386) | Arkray, Inc. | 2002-09-17 |
| URS-IG (GLUCOSE TEST) (K020175) | Teco Diagnostics | 2002-03-21 |
| URISYS 2400 URINE TEST STRIP (K012397) | Roche Diagnostics Corp. | 2001-09-26 |
| DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 (K010973) | Hypoguard USA, Inc. | 2001-09-11 |
| MEDI-TEST COMBI 11 (K991927) | Macherey-Nagel-Duren | 1999-09-17 |
| DBEST REAGENT STRIP FOR URINALYSIS (K973142) | Ameritek, Inc. | 1997-10-20 |
| CLINISTRIP (K970250) | Teco Diagnostics | 1997-04-08 |
| HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST (K954968) | Tcpi, Inc. | 1996-07-26 |
| DIA SCREEN 10 WAY REAGENT STRIPS (K961375) | Genesis Labs, Inc. | 1996-06-18 |
| FIRST CHOICE GLUCOSE URINE TEST STRIPS (K953661) | Polymer Technology Intl. | 1996-06-14 |
| BIOSCAN (K952307) | Biosys Laboratories, Inc. | 1995-09-05 |
| DIA SCREEN REAGENT STRIPS (K952971) | Genesis Labs, Inc. | 1995-08-11 |
| IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET (K942648) | Teco Diagnostics | 1995-03-24 |
| URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD (K946116) | Chemtech Labs, Inc. | 1995-03-21 |
| URINE REAGENT STRIP-3 PARAMETERS (K940469) | Teco Diagnostics | 1994-09-09 |
| BIOSCAN REAGENT STRIPS (K940043) | Bioscan Instruments, Inc. | 1994-04-12 |
| UROPAPER EIKEN 6B (K932368) | Tanabe U.S.A., Inc. | 1994-01-13 |
| UROPAPER EIKEN HAG (K932366) | Tanabe U.S.A., Inc. | 1993-11-26 |
| UROPAPER EIKEN AG (K932365) | Tanabe U.S.A., Inc. | 1993-11-26 |
| UROPAPER EIKEN 8 (K932367) | Tanabe U.S.A., Inc. | 1993-11-16 |
| UROPAPER EIKEN GK (K932363) | Tanabe U.S.A., Inc. | 1993-11-16 |
| UROPAPER (K931897) | Tanabe U.S.A., Inc. | 1993-11-16 |
| UROPAPER EIKEN 7 (K932369) | Tanabe U.S.A., Inc. | 1993-11-16 |
| UROPAPER EIKEN GP (K932364) | Tanabe U.S.A., Inc. | 1993-11-16 |
| CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS (K896454) | Boehringer Mannheim Corp. | 1990-01-11 |
| CHARISE CHARLES REAGENT STRIPS (K895282) | Lee Import Domestic Consulting | 1990-01-10 |
| DIABETES RISK DETECTOR (K864544) | Pearce Clinical Laboratories, Inc. | 1987-07-27 |
| MAJOR QUALITY GLUCOSE AND KETONES URINE TEST (K870500) | American Diagnostic Corp. | 1987-03-06 |
| BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS (K861255) | Behring Diagnostics, Inc. | 1986-10-03 |
| ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS (K861733) | Kyoto Diagnostics, Inc. | 1986-07-25 |
| BIOTEL (TM)/ DIABETES (K855239) | American Diagnostic Corp. | 1986-06-13 |
| UROPAPER EIKEN 7 (K843754) | Syn-Kit, Inc. | 1984-12-18 |
| UROPAPER EIKEN G (K843760) | Syn-Kit, Inc. | 1984-12-18 |
| UROPAPER EIKEN 5 (K843756) | Syn-Kit, Inc. | 1984-12-18 |
| UROPAPER EIKEN GK (K843758) | Syn-Kit, Inc. | 1984-12-18 |
| UROPAPER EIKEN AG (K843757) | Syn-Kit, Inc. | 1984-12-18 |
| UROPAPER EIKEN GP (K843753) | Syn-Kit, Inc. | 1984-12-18 |
| UROPAPER EIKEN 6B (K843755) | Syn-Kit, Inc. | 1984-12-18 |
| UROPAPER EIKEN HAG (K843759) | Syn-Kit, Inc. | 1984-12-18 |
| KYOTEST 2V, URINE TEST REAGENT STRIP (K841714) | Kyoto Diagnostics, Inc. | 1984-05-31 |
| KYOTEST UG URINE TEST REAGENT STRIP (K841713) | Kyoto Diagnostics, Inc. | 1984-05-31 |
| YD STRIP GPH U21 (K834387) | Yd Pharmaceutical Corp. | 1984-05-14 |
| YD STRIP GP U20 (K834386) | Yd Pharmaceutical Corp. | 1984-05-14 |
| YD STRIP GLUCOSE U19 (K834385) | Yd Pharmaceutical Corp. | 1984-05-11 |
| KYOTEST UGK (K840829) | Kyoto Diagnostics, Inc. | 1984-04-19 |
| DIASTIX REAGENT STRIPS FOR URINALYSIS (K831600) | Miles Laboratories, Inc. | 1983-09-08 |
| URI-TEST 3, INLAB REAGENT STRIPS-URINAL (K831498) | Laprol Scientific, Inc. | 1983-06-22 |
| BIOSTRIP G (K820594) | Helena Laboratories | 1982-05-05 |
| UROPAPER EIKEN UHAG (K811816) | Syn-Kit, Inc. | 1981-12-08 |
| UROPAPER EIKEN UAG (K811818) | Syn-Kit, Inc. | 1981-07-23 |
| UROPAPER EIKEN AG (K811817) | Syn-Kit, Inc. | 1981-07-15 |
| 9-WAY URINE TEST WITH ASCORBIC (K771755) | Miles Laboratories, Inc. | 1977-10-25 |
| MEGA-DIASTIX (K761310) | Miles Laboratories, Inc. | 1977-03-21 |
| CHEMSTRIP G (K770271) | Boehringer Mannheim Corp. | 1977-03-16 |