AUTION EYE AI-4510 Urine Particle Analysis System
Arkray, Inc.
ARKRAY, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9611444 | 3002807423 | ARKRAY, INC. | 1 | N | 2026-01-01 | Yousuien-nai 59 Gansuin-cho, Kamigyo-ku Kyoto JP 602-0008 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 10528 | 1412795006 | K980908 | LACTATE PRO SYSTEM | KHP | 1998-09-11 |
| 10528 | 1043539879 | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | LKM | 2024-05-03 |
| 10528 | 1694283926 | K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | QRL | 2022-10-17 |
| 10528 | 1182825121 | K200788 | Assure Titanium Blood Glucose Monitoring System | PZI | 2022-05-23 |
| 10528 | 1953779755 | K193514 | AUTION MAX AX-4060 Urinalysis System | JIL | 2023-04-13 |
| 10528 | 1746403176 | K170064 | GLUCOCARD W Blood Glucose Monitoring System | NBW | 2017-08-16 |
| 10528 | 2031694356 | K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | PDJ | 2017-06-29 |
| 10528 | 1620191276 | K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | JIL | 2016-10-07 |
| 10528 | 1448442989 | K142336 | GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System | CGA | 2014-09-17 |
| 10528 | 1889606129 | K142262 | AUTION CHECK PLUS | JJW | 2015-04-10 |
| 10528 | 1912531238 | K142035 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2014-09-05 |
| 10528 | 1292823352 | K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2014-06-30 |
| 10528 | 2001029771 | K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | KQO | 2013-02-01 |
| 10528 | 1259734516 | K093819 | ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) | NBW | 2010-06-09 |
| 10528 | 1734320881 | K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | KQO | 2009-12-23 |
| 10528 | 1466259110 | K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2009-11-24 |
| 10528 | 1866396844 | K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | CGA | 2009-10-23 |
| 10528 | 2068103172 | K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | CGA | 2008-10-21 |
| 10528 | 2030727668 | K073416 | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | CGA | 2008-06-13 |
| 10528 | 1165850451 | K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | CIC | 2006-03-24 |
| 10528 | 1629098844 | K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | CGS | 2006-01-31 |
| 10528 | 1116720016 | K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | CIG | 2005-06-17 |
| 10528 | 1510844567 | K050790 | SPOTCHEM II LDH TEST | CFH | 2005-06-06 |
| 10528 | 1111514405 | K050652 | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | CGX | 2005-04-06 |
| 10528 | 1984754746 | K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | CIC | 2005-02-15 |
| 10528 | 1310964465 | K042443 | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL | CHH | 2004-11-24 |
| 10528 | 1701712399 | K041427 | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS | CGA | 2004-11-24 |
| 10528 | 1212193818 | K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | JJF | 2004-06-16 |
| 10528 | 1373822217 | K030600 | AUTION JET AJ-4270 URINE ANALYZER | KQO | 2003-07-11 |
| 10528 | 1485842296 | K013783 | AUTION MAX AX-4280 URINALYSIS SYSTEM | KQO | 2002-01-18 |
| 10528 | 1717919840 | ||||
| 10528 | 1885413902 | ||||
| 10528 | 1248308981 | ||||
| 10528 | 1342084490 | ||||
| 10528 | 1344439273 | ||||
| 10528 | 1521931170 | ||||
| 10528 | 1645158488 | ||||
| 10528 | 2059306361 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CGA | 7 | 2014-09-17 |
| KQO | 4 | 2013-02-01 |
| NBW | 3 | 2017-08-16 |
| JIL | 2 | 2023-04-13 |
| CIC | 2 | 2006-03-24 |
| LKM | 1 | 2024-05-03 |
| QRL | 1 | 2022-10-17 |
| PZI | 1 | 2022-05-23 |
| PDJ | 1 | 2017-06-29 |
| JJW | 1 | 2015-04-10 |
| CGS | 1 | 2006-01-31 |
| CIG | 1 | 2005-06-17 |
| CFH | 1 | 2005-06-06 |
| CGX | 1 | 2005-04-06 |
| CHH | 1 | 2004-11-24 |
| JJF | 1 | 2004-06-16 |
| KHP | 1 | 1998-09-11 |
PMN#
AUTION MAX AX-4060 Urinalysis System
Arkray, Inc.
Multi-Lancet Device 2, ReliOn Premier Lancing Device
Arkray, Inc.
Assure Titanium Blood Glucose Monitoring System
Arkray, Inc.
AUTION ELEVEN Semi-Automated Urinalysis System
ARKRAY, Inc.
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
ARKRAY, INC.
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
ARKRAY, INC.
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
ARKRAY, INC.
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
ARKRAY, INC.
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
ARKRAY, INC.
SPOTCHEM II LDH TEST
ARKRAY, INC.
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
ARKRAY, INC.
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
ARKRAY, INC.
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
ARKRAY, INC.
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
ARKRAY, INC.
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
ARKRAY, INC.
ARKIT HBA1C
ARKRAY, INC.
POCKETCHEM UA AUTION STICKS 10TA
ARKRAY, INC.