Arkray, Inc. - FDA 510(k) Cleared Devices
18
Total
18
Cleared
0
Denied
Arkray, Inc. has 18 FDA 510(k) cleared chemistry devices. Based in Beverly, US.
Latest FDA clearance: May 2024. Active since 2002.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Arkray Factory USA, Inc. as regulatory consultant.
18 devices
Cleared
May 03, 2024
AUTION EYE AI-4510 Urine Particle Analysis System
Immunology
266d
Cleared
Apr 13, 2023
AUTION MAX AX-4060 Urinalysis System
Chemistry
1211d
Cleared
Oct 17, 2022
Multi-Lancet Device 2, ReliOn Premier Lancing Device
General & Plastic Surgery
175d
Cleared
May 23, 2022
Assure Titanium Blood Glucose Monitoring System
Chemistry
788d
Cleared
Oct 07, 2016
AUTION ELEVEN Semi-Automated Urinalysis System
Chemistry
269d
Cleared
Feb 01, 2013
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM
Chemistry
261d
Cleared
Dec 23, 2009
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
Chemistry
83d
Cleared
Mar 24, 2006
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
Chemistry
108d
Cleared
Jan 31, 2006
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
Chemistry
224d
Cleared
Jun 17, 2005
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
Chemistry
16d
Cleared
Jun 06, 2005
SPOTCHEM II LDH TEST
Chemistry
70d
Cleared
Apr 06, 2005
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
Chemistry
23d
Cleared
Feb 15, 2005
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
Chemistry
34d
Cleared
Nov 24, 2004
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
Chemistry
180d
Cleared
Nov 24, 2004
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
Chemistry
76d
Cleared
Jun 16, 2004
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
Chemistry
127d
Cleared
Sep 02, 2003
ARKIT HBA1C
Chemistry
193d
Cleared
Sep 17, 2002
POCKETCHEM UA AUTION STICKS 10TA
Chemistry
57d