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Arkray, Inc.

18 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
AUTION EYE AI-4510 Urine Particle Analysis System (K232416)Arkray, Inc.2024-05-03
AUTION MAX AX-4060 Urinalysis System (K193514)Arkray, Inc.2023-04-13
Multi-Lancet Device 2, ReliOn Premier Lancing Device (K221175)Arkray, Inc.2022-10-17
Assure Titanium Blood Glucose Monitoring System (K200788)Arkray, Inc.2022-05-23
AUTION ELEVEN Semi-Automated Urinalysis System (K160062)Arkray, Inc.2016-10-07
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL (K121456)Arkray, Inc.2013-02-01
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (K093098)Arkray, Inc.2009-12-23
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (K053401)Arkray, Inc.2006-03-24
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (K051648)Arkray, Inc.2006-01-31
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (K051432)Arkray, Inc.2005-06-17
SPOTCHEM II LDH TEST (K050790)Arkray, Inc.2005-06-06
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS (K050652)Arkray, Inc.2005-04-06
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (K050077)Arkray, Inc.2005-02-15
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL (K042443)Arkray, Inc.2004-11-24
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS (K041427)Arkray, Inc.2004-11-24
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (K040332)Arkray, Inc.2004-06-16
ARKIT HBA1C (K030553)Arkray, Inc.2003-09-02
POCKETCHEM UA AUTION STICKS 10TA (K022386)Arkray, Inc.2002-09-17

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Every clearance here is in the API, with alerts when new ones post.