Company ยท US
Arkray, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2024. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGA | Glucose Oxidase, Glucose | 3 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 3 |
| CIC | Cresolphthalein Complexone, Calcium | 2 |
| KQO | Automated Urinalysis System | 2 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 |
| LJX | Test, Urine Leukocyte | 1 |
| LKM | Counter, Urine Particle | 1 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | 1 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 2024 | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System Arkray, Inc., JP | LKM |
| Apr 13, 2023 | K193514 | AUTION MAX AX-4060 Urinalysis System Arkray, Inc., JP | JIL |
| Oct 17, 2022 | K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device Arkray, Inc., JP | QRL |
| May 23, 2022 | K200788 | Assure Titanium Blood Glucose Monitoring System Arkray, Inc., JP | PZI |
| Oct 7, 2016 | K160062 | AUTION ELEVEN Semi-Automated Urinalysis System Arkray, Inc., JP | JIL |
| Feb 1, 2013 | K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL Arkray, Inc. | KQO |
| Dec 23, 2009 | K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM Arkray, Inc. | KQO |
| Dec 20, 2006 | K063068 | FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 Arkray USA, Inc. | NBW |
| Mar 24, 2006 | K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS Arkray, Inc. | CIC |
| Jan 31, 2006 | K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS Arkray, Inc. | CGS |
| Jun 17, 2005 | K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS Arkray, Inc. | CIG |
| Jun 6, 2005 | K050790 | SPOTCHEM II LDH TEST Arkray, Inc. | CFH |
| Apr 6, 2005 | K050652 | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS Arkray, Inc. | CGX |
| Feb 15, 2005 | K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS Arkray, Inc. | CIC |
| Nov 24, 2004 | K042443 | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL Arkray, Inc. | CHH |
| Nov 24, 2004 | K041427 | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS Arkray, Inc. | CGA |
| Jun 16, 2004 | K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER Arkray, Inc. | JJF |
| Sep 2, 2003 | K030553 | ARKIT HBA1C Arkray, Inc. | LCP |
| Sep 17, 2002 | K022386 | POCKETCHEM UA AUTION STICKS 10TA Arkray, Inc. | JIL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2010 | ARKRAY USA INC. Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400. Terminated |
LJX | K981555 |
| Feb 1, 2008 | ARKRAY USA INC. Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan. Terminated |
CGA | K002621 K011233 |
| Dec 13, 2007 | ARKRAY USA INC. Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents Terminated |
CGA | None listed |