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Arkray, Inc.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K232416 AUTION EYE AI-4510 Urine Particle Analysis SystemLKM2024-05-03 View
510(k) K193514 AUTION MAX AX-4060 Urinalysis SystemJIL2023-04-13 View
510(k) K221175 Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL2022-10-17 View
510(k) K200788 Assure Titanium Blood Glucose Monitoring SystemPZI2022-05-23 View
510(k) K160062 AUTION ELEVEN Semi-Automated Urinalysis SystemJIL2016-10-07 View
510(k) K121456 AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLKQO2013-02-01 View
510(k) K093098 AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMKQO2009-12-23 View
510(k) K053401 SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSCIC2006-03-24 View
510(k) K051648 SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTSCGS2006-01-31 View
510(k) K051432 SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTSCIG2005-06-17 View
510(k) K050790 SPOTCHEM II LDH TESTCFH2005-06-06 View
510(k) K050652 SPOTCHEM II CREATININE, AMYLASE & ALP TESTSCGX2005-04-06 View
510(k) K050077 SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSCIC2005-02-15 View
510(k) K042443 SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANELCHH2004-11-24 View
510(k) K041427 THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTSCGA2004-11-24 View
510(k) K040332 POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERJJF2004-06-16 View
510(k) K030553 ARKIT HBA1CLCP2003-09-02 View
510(k) K022386 POCKETCHEM UA AUTION STICKS 10TAJIL2002-09-17 View
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