Product code JIN
- Device name
- Nitroprusside, Ketones (Urinary, Non-Quant.)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1435
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201551 | KetoSens BT Blood B-Ketone Monitoring System | I-Sens, Inc. | 2020-09-09 |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 |
| K182593 | KET-1 Blood Ketone Monitoring System | Apex BioTechnology Corp. | 2018-12-18 |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | Taidoc Technology Corporation | 2018-05-04 |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | I-Sens, Inc. | 2018-04-13 |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis | ACON Laboratories, Inc. | 2017-07-06 |
| K060768 | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS | Abbott Diabetes Care, Inc. | 2006-04-21 |
| K033114 | KETOCHECKS | Neo Diagnostics, Inc. | 2004-04-26 |
| K003987 | URS-1K (KETONE TESST) | Teco Diagnostics | 2001-04-26 |
| K953680 | FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-12 |
| K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON | Gds Technology, LLC | 1991-07-01 |
| K912373 | KETO-340 II | Ihara Medics U.S., Inc. | 1991-07-01 |
| K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED | Gds Diagnostics | 1991-03-04 |
| K903365 | KETOREX SANWA STANDARDS | Ihara Medics U.S., Inc. | 1990-12-20 |
| K903366 | KETONE TEST B SANWA STANDARD | Ihara Medics U.S., Inc. | 1990-11-20 |
| K903367 | KETONE TEST A SANWA STANDARD | Ihara Medics U.S., Inc. | 1990-11-20 |
| K875029 | ABBOTT BREATH ACETONE ANALYZER | Abbott Laboratories | 1988-05-27 |
| K850368 | SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV | Sigma Chemical Co. | 1985-08-30 |
| K841715 | KYOTEST UK URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | 1984-05-31 |
| K831499 | GLUCOSE 3, INLAB REAGENT STRIPS-URINALY | Laprol Scientific, Inc. | 1983-06-17 |
| K830975 | PLAN A LIFE | New Directions Co. | 1983-05-04 |
| K830976 | HELENA BIOSTRIP K | Helena Laboratories | 1983-05-04 |
| K801270 | TEST FOR KETONE IN URINE(ACETOACETIC AC | Miles Laboratories, Inc. | 1980-07-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10612479279886 | Mckesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-09-18 |
| 08806141303497 | One+Step 10A | DFI CO.,LTD | 2023-10-16 |
| 08806141302209 | Just Fitter 10 Parameter Test Strips | DFI CO.,LTD | 2020-09-22 |
| 08806141302070 | CYBOW 10 | DFI CO.,LTD | 2020-06-29 |
| 08806141301998 | Yodoc 10 | DFI CO.,LTD | 2020-02-20 |
| 10301932883509 | KETO-DIASTIX® | ASCENSIA DIABETES CARE US INC. | 2019-06-06 |
| 10301932882212 | KETO-DIASTIX® | ASCENSIA DIABETES CARE US INC. | 2019-06-06 |
| 10301932880508 | KETOSTIX® | ASCENSIA DIABETES CARE US INC. | 2019-06-06 |
| 10301932881215 | KETOSTIX® | ASCENSIA DIABETES CARE US INC. | 2019-06-06 |
| 08806141301479 | QTEST™ 11 | DFI CO.,LTD | 2018-12-21 |
| 08806125680279 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680286 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680217 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-12-21 |
| 10607415001294 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415002055 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415002062 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183497 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183527 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479197463 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 08806141300755 | CYBOW 11 | DFI CO.,LTD | 2016-10-06 |
| 10673486000054 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000047 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000061 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000030 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000023 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000016 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10385480534939 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 08806125680231 | URiSCAN 10 ACR strip | YD Diagnostics CORP. | 2016-08-05 |
| 08806125680019 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-08-05 |