FDA Product Code
FDA Product Code JIL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1340
510(k) Clearances — 81 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193514 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | 2023-04-13 | Traditional | PDF ↗ |
| K183432 | cobas u 601 urinalysis test system | Roche Diagnostics | 2019-05-07 | Traditional | PDF ↗ |
| K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | 2018-07-18 | Traditional | PDF ↗ |
| K180356 | inui In-Home Urine Analysis Test System | Scanadu, Inc. | 2018-05-25 | Traditional | PDF ↗ |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | DFI Co., Ltd. | 2018-05-23 | Traditional | PDF ↗ |
| K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | 2018-02-16 | Traditional | PDF ↗ |
| K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017-05-12 | Traditional | PDF ↗ |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | 2016-10-07 | Traditional | PDF ↗ |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-07-22 | Traditional | PDF ↗ |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Teco Diagnostics | 2015-07-24 | Traditional | PDF ↗ |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | Teco Diagnostics | 2014-05-29 | Traditional | PDF ↗ |
| K120124 | FORESIGHT U120 URINE ANALYZER | ACON Laboratories, Inc. | 2012-03-06 | Special | PDF ↗ |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | Teco Diagnostics | 2011-02-04 | Traditional | PDF ↗ |
| K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 | Siemens Healthcare Diagnostics | 2009-10-09 | Traditional | PDF ↗ |
| K061812 | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 | Analyticon Biotechnologies AG | 2007-04-06 | Traditional | PDF ↗ |
| K061846 | COMBI SCAN100 | Analyticon Biotechnologies AG | 2007-04-06 | Traditional | PDF ↗ |
| K063390 | URINE CHEMISTRY ANALYZER UR-50 | Ind Diagnostic, Inc. | 2007-03-01 | Traditional | PDF ↗ |
| K063276 | CLINITEK ADVANTUS, MODEL 1420 | Bayer Healthcare, LLC | 2006-12-28 | Traditional | PDF ↗ |
| K061742 | URYXXON RELAX URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | 2006-09-06 | Special | PDF ↗ |
| K060280 | ICHEM 100 URINE CHEMISTRY ANALYZER | Iris International, Inc. | 2006-06-13 | Traditional | PDF ↗ |
| K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | DFI Co., Ltd. | 2006-03-29 | Traditional | PDF ↗ |
| K051034 | URYXXON 200 URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | 2005-11-22 | Traditional | PDF ↗ |
| K050801 | URISCAN OPTIMA II URINE ANALYZER | Yd Diagnostics | 2005-04-20 | Special | PDF ↗ |
| K042641 | CHEMVIEW-10 | Cenogenics Corp. | 2005-01-07 | Traditional | PDF ↗ |
| K033851 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) | Hypoguard USA, Inc. | 2004-03-02 | Traditional | PDF ↗ |
| K023885 | COMBI-SCREEN, MODELS 10SL AND 11SL | Analyticon Biotechnologies AG | 2003-10-21 | Traditional | PDF ↗ |
| K032437 | CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS | Roche Diagnostics Corp. | 2003-10-08 | Traditional | PDF ↗ |
| K022386 | POCKETCHEM UA AUTION STICKS 10TA | Arkray, Inc. | 2002-09-17 | Traditional | PDF ↗ |
| K020175 | URS-IG (GLUCOSE TEST) | Teco Diagnostics | 2002-03-21 | Traditional | PDF ↗ |
| K012397 | URISYS 2400 URINE TEST STRIP | Roche Diagnostics Corp. | 2001-09-26 | Traditional | PDF ↗ |
| K010973 | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 | Hypoguard USA, Inc. | 2001-09-11 | Traditional | PDF ↗ |
| K991927 | MEDI-TEST COMBI 11 | Macherey-Nagel-Duren | 1999-09-17 | Traditional | PDF ↗ |
| K973142 | DBEST REAGENT STRIP FOR URINALYSIS | Ameritek, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K970250 | CLINISTRIP | Teco Diagnostics | 1997-04-08 | Traditional | PDF ↗ |
| K954968 | HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST | Tcpi, Inc. | 1996-07-26 | Traditional | PDF ↗ |
| K961375 | DIA SCREEN 10 WAY REAGENT STRIPS | Genesis Labs, Inc. | 1996-06-18 | Traditional | PDF ↗ |
| K953661 | FIRST CHOICE GLUCOSE URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-14 | Traditional | PDF ↗ |
| K952307 | BIOSCAN | Biosys Laboratories, Inc. | 1995-09-05 | Traditional | PDF ↗ |
| K952971 | DIA SCREEN REAGENT STRIPS | Genesis Labs, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K942648 | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET | Teco Diagnostics | 1995-03-24 | Traditional | PDF ↗ |
| K946116 | URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD | Chemtech Labs, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K940469 | URINE REAGENT STRIP-3 PARAMETERS | Teco Diagnostics | 1994-09-09 | Traditional | PDF ↗ |
| K940043 | BIOSCAN REAGENT STRIPS | Bioscan Instruments, Inc. | 1994-04-12 | Traditional | PDF ↗ |
| K932368 | UROPAPER EIKEN 6B | Tanabe U.S.A., Inc. | 1994-01-13 | Traditional | PDF ↗ |
| K932366 | UROPAPER EIKEN HAG | Tanabe U.S.A., Inc. | 1993-11-26 | Traditional | PDF ↗ |
| K932365 | UROPAPER EIKEN AG | Tanabe U.S.A., Inc. | 1993-11-26 | Traditional | PDF ↗ |
| K931897 | UROPAPER | Tanabe U.S.A., Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K932369 | UROPAPER EIKEN 7 | Tanabe U.S.A., Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K932367 | UROPAPER EIKEN 8 | Tanabe U.S.A., Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K932364 | UROPAPER EIKEN GP | Tanabe U.S.A., Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K932363 | UROPAPER EIKEN GK | Tanabe U.S.A., Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K896454 | CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS | Boehringer Mannheim Corp. | 1990-01-11 | Traditional | PDF ↗ |
| K895282 | CHARISE CHARLES REAGENT STRIPS | Lee Import Domestic Consulting | 1990-01-10 | Traditional | PDF ↗ |
| K864544 | DIABETES RISK DETECTOR | Pearce Clinical Laboratories, Inc. | 1987-07-27 | Traditional | PDF ↗ |
| K870500 | MAJOR QUALITY GLUCOSE AND KETONES URINE TEST | American Diagnostic Corp. | 1987-03-06 | Traditional | PDF ↗ |
| K861255 | BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS | Behring Diagnostics, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K861733 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS | Kyoto Diagnostics, Inc. | 1986-07-25 | Traditional | PDF ↗ |
| K855239 | BIOTEL (TM)/ DIABETES | American Diagnostic Corp. | 1986-06-13 | Traditional | PDF ↗ |
| K843756 | UROPAPER EIKEN 5 | Syn-Kit, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K843755 | UROPAPER EIKEN 6B | Syn-Kit, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K843759 | UROPAPER EIKEN HAG | Syn-Kit, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K843760 | UROPAPER EIKEN G | Syn-Kit, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K843754 | UROPAPER EIKEN 7 | Syn-Kit, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K843757 | UROPAPER EIKEN AG | Syn-Kit, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K843753 | UROPAPER EIKEN GP | Syn-Kit, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K843758 | UROPAPER EIKEN GK | Syn-Kit, Inc. | 1984-12-18 | Traditional | PDF ↗ |
| K841714 | KYOTEST 2V, URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | 1984-05-31 | Traditional | PDF ↗ |
| K841713 | KYOTEST UG URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | 1984-05-31 | Traditional | PDF ↗ |
| K834387 | YD STRIP GPH U21 | Yd Pharmaceutical Corp. | 1984-05-14 | Traditional | PDF ↗ |
| K834386 | YD STRIP GP U20 | Yd Pharmaceutical Corp. | 1984-05-14 | Traditional | PDF ↗ |
| K834385 | YD STRIP GLUCOSE U19 | Yd Pharmaceutical Corp. | 1984-05-11 | Traditional | PDF ↗ |
| K840829 | KYOTEST UGK | Kyoto Diagnostics, Inc. | 1984-04-19 | Traditional | PDF ↗ |
| K831600 | DIASTIX REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | 1983-09-08 | Traditional | PDF ↗ |
| K831498 | URI-TEST 3, INLAB REAGENT STRIPS-URINAL | Laprol Scientific, Inc. | 1983-06-22 | Traditional | PDF ↗ |
| K820594 | BIOSTRIP G | Helena Laboratories | 1982-05-05 | Traditional | PDF ↗ |
| K811816 | UROPAPER EIKEN UHAG | Syn-Kit, Inc. | 1981-12-08 | Traditional | PDF ↗ |
| K811818 | UROPAPER EIKEN UAG | Syn-Kit, Inc. | 1981-07-23 | Traditional | PDF ↗ |
| K811817 | UROPAPER EIKEN AG | Syn-Kit, Inc. | 1981-07-15 | Traditional | PDF ↗ |
| K771755 | 9-WAY URINE TEST WITH ASCORBIC | Miles Laboratories, Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K761310 | MEGA-DIASTIX | Miles Laboratories, Inc. | 1977-03-21 | Traditional | PDF ↗ |
| K770271 | CHEMSTRIP G | Boehringer Mannheim Corp. | 1977-03-16 | Traditional | PDF ↗ |
Product code JIL · Class II · Clinical Chemistry. Data: openFDA.