FDA Product Code
FDA Product Code JIN — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1435
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201551 | KetoSens BT Blood B-Ketone Monitoring System | I-Sens, Inc. | 2020-09-09 | Special | PDF ↗ |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 | Traditional | PDF ↗ |
| K182593 | KET-1 Blood Ketone Monitoring System | Apex BioTechnology Corp. | 2018-12-18 | Traditional | PDF ↗ |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | Taidoc Technology Corporation | 2018-05-04 | Traditional | PDF ↗ |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | I-Sens, Inc. | 2018-04-13 | Traditional | PDF ↗ |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis | ACON Laboratories, Inc. | 2017-07-06 | Traditional | PDF ↗ |
| K060768 | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS | Abbott Diabetes Care, Inc. | 2006-04-21 | Special | PDF ↗ |
| K033114 | KETOCHECKS | Neo Diagnostics, Inc. | 2004-04-26 | Traditional | PDF ↗ |
| K003987 | URS-1K (KETONE TESST) | Teco Diagnostics | 2001-04-26 | Traditional | PDF ↗ |
| K953662 | FIRST CHOICE KETONES URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-14 | Traditional | PDF ↗ |
| K953680 | FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-12 | Traditional | PDF ↗ |
| K912373 | KETO-340 II | Ihara Medics U.S., Inc. | 1991-07-01 | Traditional | PDF ↗ |
| K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON | Gds Technology, LLC | 1991-07-01 | Traditional | PDF ↗ |
| K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED | Gds Diagnostics | 1991-03-04 | Traditional | PDF ↗ |
| K903365 | KETOREX SANWA STANDARDS | Ihara Medics U.S., Inc. | 1990-12-20 | Traditional | PDF ↗ |
| K903367 | KETONE TEST A SANWA STANDARD | Ihara Medics U.S., Inc. | 1990-11-20 | Traditional | PDF ↗ |
| K903366 | KETONE TEST B SANWA STANDARD | Ihara Medics U.S., Inc. | 1990-11-20 | Traditional | PDF ↗ |
| K875029 | ABBOTT BREATH ACETONE ANALYZER | Abbott Laboratories | 1988-05-27 | Traditional | PDF ↗ |
| K850368 | SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV | Sigma Chemical Co. | 1985-08-30 | Traditional | PDF ↗ |
| K841715 | KYOTEST UK URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | 1984-05-31 | Traditional | PDF ↗ |
| K831499 | GLUCOSE 3, INLAB REAGENT STRIPS-URINALY | Laprol Scientific, Inc. | 1983-06-17 | Traditional | PDF ↗ |
| K830975 | PLAN A LIFE | New Directions Co. | 1983-05-04 | Traditional | PDF ↗ |
| K830976 | HELENA BIOSTRIP K | Helena Laboratories | 1983-05-04 | Traditional | PDF ↗ |
| K801270 | TEST FOR KETONE IN URINE(ACETOACETIC AC | Miles Laboratories, Inc. | 1980-07-08 | Traditional | PDF ↗ |
Product code JIN · Class I · Clinical Chemistry. Data: openFDA.