Arkray, Inc. - FDA 510(k) Cleared Devices
18
Total
18
Cleared
0
Denied
FDA 510(k) cleared devices by Arkray, Inc. Chemistry ✕
16 devices
Cleared
Apr 13, 2023
AUTION MAX AX-4060 Urinalysis System
Chemistry
1211d
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