Panels › Clinical Chemistry › Product code JIN · Class 1
Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation 862.1435
0510(k)s in 12 months (24 all time)
2recalls in 12 months (14 all time)
6recalls that name a 510(k)
Top companies in JIN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2020 | K201551 | KetoSens BT Blood B-Ketone Monitoring System I-Sens, Inc., KR | JIN |
| Jun 5, 2020 | K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System Vivachek Biotech (Hangzhou) Co., Ltd., CN | JIN |
| Dec 18, 2018 | K182593 | KET-1 Blood Ketone Monitoring System Apex BioTechnology Corp., TW | JIN |
| May 4, 2018 | K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System Taidoc Technology Corporation, TW | JIN |
| Apr 13, 2018 | K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System I-Sens, Inc., KR | JIN |
| Jul 6, 2017 | K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis ACON Laboratories, Inc. | JIN |
| Apr 21, 2006 | K060768 | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS Abbott Diabetes Care, Inc. | JIN |
| Apr 26, 2004 | K033114 | KETOCHECKS Neo Diagnostics, Inc. | JIN |
| Apr 26, 2001 | K003987 | URS-1K (KETONE TESST) Teco Diagnostics | JIN |
| Jun 14, 1996 | K953662 | FIRST CHOICE KETONES URINE TEST STRIPS Polymer Technology Intl. | JIN |
| Jun 12, 1996 | K953680 | FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS Polymer Technology Intl. | JIN |
| Jul 1, 1991 | K912373 | KETO-340 II Ihara Medics U.S., Inc. | JIN |
| Jul 1, 1991 | K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON Gds Technology, LLC | JIN |
| Mar 4, 1991 | K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED Gds Diagnostics | JIN |
| Dec 20, 1990 | K903365 | KETOREX SANWA STANDARDS Ihara Medics U.S., Inc. | JIN |
| Nov 20, 1990 | K903367 | KETONE TEST A SANWA STANDARD Ihara Medics U.S., Inc. | JIN |
| Nov 20, 1990 | K903366 | KETONE TEST B SANWA STANDARD Ihara Medics U.S., Inc. | JIN |
| May 27, 1988 | K875029 | ABBOTT BREATH ACETONE ANALYZER Abbott Laboratories | JIN |
| Aug 30, 1985 | K850368 | SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV Sigma Chemical Co. | JIN |
| May 31, 1984 | K841715 | KYOTEST UK URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. | JIN |
| Jun 17, 1983 | K831499 | GLUCOSE 3, INLAB REAGENT STRIPS-URINALY Laprol Scientific, Inc. | JIN |
| May 4, 1983 | K830976 | HELENA BIOSTRIP K Helena Laboratories | JIN |
| May 4, 1983 | K830975 | PLAN A LIFE New Directions Co. | JIN |
| Jul 8, 1980 | K801270 | TEST FOR KETONE IN URINE(ACETOACETIC AC Miles Laboratories, Inc. | JIN |
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