Panels › Clinical Chemistry › Product code JIL · Class 2
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation 862.1340
0510(k)s in 12 months (81 all time)
1recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in JIL
| Company | 510(k)s | Recalls |
|---|---|---|
| Syn-Kit, Inc. | 11 | 0 |
| Tanabe U.S.A., Inc. | 8 | 0 |
| Teco Diagnostics | 8 | 0 |
| Kyoto Diagnostics, Inc. | 4 | 0 |
| Siemens Healthcare Diagnostics | 1 | 3 |
| Analyticon Biotechnologies AG | 3 | 0 |
| Arkray, Inc. | 3 | 0 |
| DFI Co., Ltd. | 3 | 0 |
| Macherey-Nagel GmbH & Co. KG | 2 | 1 |
| Miles Laboratories, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 13, 2023 | K193514 | AUTION MAX AX-4060 Urinalysis System Arkray, Inc., JP | JIL |
| May 7, 2019 | K183432 | cobas u 601 urinalysis test system Roche Diagnostics | JIL |
| Jul 18, 2018 | K173327 | DIP/U.S. Urine Analysis Test System Healthy.Io, Ltd., IL | JIL |
| May 25, 2018 | K180356 | inui In-Home Urine Analysis Test System Scanadu, Inc. | JIL |
| May 23, 2018 | K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips DFI Co., Ltd., KR | JIL |
| Feb 16, 2018 | K171521 | DUS R-50S (Urine Chemistry system) DFI Co., Ltd., KR | JIL |
| May 12, 2017 | K171083 | iChemVELOCITY Automated Urine Chemistry System Iris Diagnostics, A Division of Iris International, Inc. | JIL |
| Oct 7, 2016 | K160062 | AUTION ELEVEN Semi-Automated Urinalysis System Arkray, Inc., JP | JIL |
| Jul 22, 2016 | K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM Teco Diagnostics, Inc. | JIL |
| Jul 24, 2015 | K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS Teco Diagnostics | JIL |
| May 29, 2014 | K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS Teco Diagnostics | JIL |
| Mar 6, 2012 | K120124 | FORESIGHT U120 URINE ANALYZER ACON Laboratories, Inc. | JIL |
| Feb 4, 2011 | K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 Teco Diagnostics | JIL |
| Oct 9, 2009 | K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 Siemens Healthcare Diagnostics | JIL |
| Apr 6, 2007 | K061846 | COMBI SCAN100 Analyticon Biotechnologies AG, DE | JIL |
| Apr 6, 2007 | K061812 | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 Analyticon Biotechnologies AG, DE | JIL |
| Mar 1, 2007 | K063390 | URINE CHEMISTRY ANALYZER UR-50 Ind Diagnostic, Inc. | JIL |
| Dec 28, 2006 | K063276 | CLINITEK ADVANTUS, MODEL 1420 Bayer Healthcare, LLC | JIL |
| Sep 6, 2006 | K061742 | URYXXON RELAX URINE ANALYZER Macherey-Nagel GmbH & Co. KG | JIL |
| Jun 13, 2006 | K060280 | ICHEM 100 URINE CHEMISTRY ANALYZER Iris International, Inc. | JIL |
| Mar 29, 2006 | K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS DFI Co., Ltd. | JIL |
| Nov 22, 2005 | K051034 | URYXXON 200 URINE ANALYZER Macherey-Nagel GmbH & Co. KG | JIL |
| Apr 20, 2005 | K050801 | URISCAN OPTIMA II URINE ANALYZER Yd Diagnostics | JIL |
| Jan 7, 2005 | K042641 | CHEMVIEW-10 Cenogenics Corp. | JIL |
| Mar 2, 2004 | K033851 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) Hypoguard USA, Inc. | JIL |
| Oct 21, 2003 | K023885 | COMBI-SCREEN, MODELS 10SL AND 11SL Analyticon Biotechnologies AG | JIL |
| Oct 8, 2003 | K032437 | CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS Roche Diagnostics Corp. | JIL |
| Sep 17, 2002 | K022386 | POCKETCHEM UA AUTION STICKS 10TA Arkray, Inc. | JIL |
| Mar 21, 2002 | K020175 | URS-IG (GLUCOSE TEST) Teco Diagnostics | JIL |
| Sep 26, 2001 | K012397 | URISYS 2400 URINE TEST STRIP Roche Diagnostics Corp. | JIL |
| Sep 11, 2001 | K010973 | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 Hypoguard USA, Inc. | JIL |
| Sep 17, 1999 | K991927 | MEDI-TEST COMBI 11 Macherey-Nagel-Duren | JIL |
| Oct 20, 1997 | K973142 | DBEST REAGENT STRIP FOR URINALYSIS Ameritek, Inc. | JIL |
| Apr 8, 1997 | K970250 | CLINISTRIP Teco Diagnostics | JIL |
| Jul 26, 1996 | K954968 | HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST Tcpi, Inc. | JIL |
| Jun 18, 1996 | K961375 | DIA SCREEN 10 WAY REAGENT STRIPS Genesis Labs, Inc. | JIL |
| Jun 14, 1996 | K953661 | FIRST CHOICE GLUCOSE URINE TEST STRIPS Polymer Technology Intl. | JIL |
| Sep 5, 1995 | K952307 | BIOSCAN Biosys Laboratories, Inc. | JIL |
| Aug 11, 1995 | K952971 | DIA SCREEN REAGENT STRIPS Genesis Labs, Inc. | JIL |
| Mar 24, 1995 | K942648 | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET Teco Diagnostics | JIL |
| Mar 21, 1995 | K946116 | URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD Chemtech Labs, Inc. | JIL |
| Sep 9, 1994 | K940469 | URINE REAGENT STRIP-3 PARAMETERS Teco Diagnostics | JIL |
| Apr 12, 1994 | K940043 | BIOSCAN REAGENT STRIPS Bioscan Instruments, Inc. | JIL |
| Jan 13, 1994 | K932368 | UROPAPER EIKEN 6B Tanabe U.S.A., Inc. | JIL |
| Nov 26, 1993 | K932366 | UROPAPER EIKEN HAG Tanabe U.S.A., Inc. | JIL |
| Nov 26, 1993 | K932365 | UROPAPER EIKEN AG Tanabe U.S.A., Inc. | JIL |
| Nov 16, 1993 | K932369 | UROPAPER EIKEN 7 Tanabe U.S.A., Inc. | JIL |
| Nov 16, 1993 | K932367 | UROPAPER EIKEN 8 Tanabe U.S.A., Inc. | JIL |
| Nov 16, 1993 | K932364 | UROPAPER EIKEN GP Tanabe U.S.A., Inc. | JIL |
| Nov 16, 1993 | K932363 | UROPAPER EIKEN GK Tanabe U.S.A., Inc. | JIL |
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