| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | May 3, 2024 |
| K193514 | AUTION MAX AX-4060 Urinalysis System | April 13, 2023 |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | October 17, 2022 |
| K200788 | Assure Titanium Blood Glucose Monitoring System | May 23, 2022 |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | October 7, 2016 |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STR | February 1, 2013 |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | December 23, 2009 |
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | March 24, 2006 |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | January 31, 2006 |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | June 17, 2005 |
| K050790 | SPOTCHEM II LDH TEST | June 6, 2005 |
| K050652 | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | April 6, 2005 |
| K050077 | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | February 15, 2005 |
| K042443 | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL | November 24, 2004 |
| K041427 | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS | November 24, 2004 |
| K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | June 16, 2004 |
| K030553 | ARKIT HBA1C | September 2, 2003 |
| K022386 | POCKETCHEM UA AUTION STICKS 10TA | September 17, 2002 |