| KetoSens BT Blood B-Ketone Monitoring System (K201551) | I-Sens, Inc. | 2020-09-09 |
| VivaChek Blood Glucose and B-Ketone Monitoring System (K192957) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 |
| KET-1 Blood Ketone Monitoring System (K182593) | Apex BioTechnology Corp. | 2018-12-18 |
| TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (K173345) | Taidoc Technology Corporation | 2018-05-04 |
| KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System (K170463) | I-Sens, Inc. | 2018-04-13 |
| On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis (K170587) | ACON Laboratories, Inc. | 2017-07-06 |
| PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (K060768) | Abbott Diabetes Care, Inc. | 2006-04-21 |
| KETOCHECKS (K033114) | Neo Diagnostics, Inc. | 2004-04-26 |
| URS-1K (KETONE TESST) (K003987) | Teco Diagnostics | 2001-04-26 |
| FIRST CHOICE KETONES URINE TEST STRIPS (K953662) | Polymer Technology Intl. | 1996-06-14 |
| FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (K953680) | Polymer Technology Intl. | 1996-06-12 |
| KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON (K911801) | Gds Technology, LLC | 1991-07-01 |
| KETO-340 II (K912373) | Ihara Medics U.S., Inc. | 1991-07-01 |
| GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED (K910108) | Gds Diagnostics | 1991-03-04 |
| KETOREX SANWA STANDARDS (K903365) | Ihara Medics U.S., Inc. | 1990-12-20 |
| KETONE TEST A SANWA STANDARD (K903367) | Ihara Medics U.S., Inc. | 1990-11-20 |
| KETONE TEST B SANWA STANDARD (K903366) | Ihara Medics U.S., Inc. | 1990-11-20 |
| ABBOTT BREATH ACETONE ANALYZER (K875029) | Abbott Laboratories | 1988-05-27 |
| SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV (K850368) | Sigma Chemical Co. | 1985-08-30 |
| KYOTEST UK URINE TEST REAGENT STRIP (K841715) | Kyoto Diagnostics, Inc. | 1984-05-31 |
| GLUCOSE 3, INLAB REAGENT STRIPS-URINALY (K831499) | Laprol Scientific, Inc. | 1983-06-17 |
| HELENA BIOSTRIP K (K830976) | Helena Laboratories | 1983-05-04 |
| PLAN A LIFE (K830975) | New Directions Co. | 1983-05-04 |
| TEST FOR KETONE IN URINE(ACETOACETIC AC (K801270) | Miles Laboratories, Inc. | 1980-07-08 |