510(k) K170463
- Device
- KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
- Applicant
- I-SENS, Inc.
- 510(k) number
- K170463
- Product code
- JIN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-13
- Date received
- 2017-02-15
- Regulation
- 862.1435
- Classification name
- Nitroprusside, Ketones (urinary, Non-quant.)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joon Ho Jung
- Address
- 43, Banpo-Daero 28-Gil Seocho-Gu Seoul KR 06646 06646
FDA Registration Numbers#
- 3005841640
- 3009238284
- 3007134734
- 3042471840
- 3006198300
- 9610633
- 3021011196
- 3030648160
- 4580
- 3009901017
- 1219029
- 3009585529
- 3042026207
- 3013679502
- 3010713600
- 3005621222
- 3030186688
- 3021247813
- 3004145393
- 3003917514
- 2030633
- 3008780388
- 3038206980
- 9616936
- 3012725363
- 1649661
- 3008987086
- 3013223546
- 3008058135
- 3038419886
- 3010852191
- 2029372
- 3003795116
- 2954323
- 3021186226
- 3010891909
- 1832816
- 2032900
- 3015341499
- 3002637618
- 1832216
- 3012421607
- 3006644620
- 3009469260
- 3031915160
- 2432235
- 8040374
- 3011121740
- 3004192065
- 3011689956
- 1000113657
- 3005644014
- 3004493545
- 9680746
- 9710094
- 1616487
- 1417592
- 3007301207
- 3043127699
- 2244821
- 3010324880
- 3009171251
- 3006371704
- 3008517993
- 1181121
- 3005360469
- 3007382160
- 3014353121
- 3016712364
- 3015413132
- 2531491
- 3015745144
- 3003422726
- 1810909
- 9615507
- 3042828169
- 3009448641
- 3013545943
- 3011979858
- 3003600763
Source Documents#
Other 510(k) Records For Product Code JIN #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary