FDA 510(k) Applications Submitted by ARKRAY, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K121456 |
05/16/2012 |
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL |
ARKRAY, INC. |
| K022386 |
07/22/2002 |
POCKETCHEM UA AUTION STICKS 10TA |
ARKRAY, INC. |
| K030553 |
02/21/2003 |
ARKIT HBA1C |
ARKRAY, INC. |
| K050077 |
01/12/2005 |
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS |
ARKRAY, INC. |
| K040332 |
02/10/2004 |
POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER |
ARKRAY, INC. |
| K050652 |
03/14/2005 |
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS |
ARKRAY, INC. |
| K050790 |
03/28/2005 |
SPOTCHEM II LDH TEST |
ARKRAY, INC. |
| K041427 |
05/28/2004 |
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS |
ARKRAY, INC. |
| K051432 |
06/01/2005 |
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS |
ARKRAY, INC. |
| K051648 |
06/21/2005 |
SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS |
ARKRAY, INC. |
| K042443 |
09/09/2004 |
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL |
ARKRAY, INC. |
| K053401 |
12/06/2005 |
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS |
ARKRAY, INC. |
| K093098 |
10/01/2009 |
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM |
ARKRAY, INC. |
| K221175 |
04/25/2022 |
Multi-Lancet Device 2, ReliOn Premier Lancing Device |
Arkray, Inc. |
| K160062 |
01/12/2016 |
AUTION ELEVEN Semi-Automated Urinalysis System |
ARKRAY, Inc. |
| K200788 |
03/26/2020 |
Assure Titanium Blood Glucose Monitoring System |
Arkray, Inc. |
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