JIN — Nitroprusside, Ketones (Urinary, Non-Quant.) Class I
FDA product code JIN covers "Nitroprusside, Ketones (Urinary, Non-Quant.)", a Class I medical device regulated under 21 CFR 862.1435. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JIN
- Device Class
- Class I
- Regulation Number
- 862.1435
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201551 | i-sens | KetoSens BT Blood B-Ketone Monitoring System | September 9, 2020 |
| K192957 | vivachek biotech (hangzhou) co | VivaChek Blood Glucose and B-Ketone Monitoring System | June 5, 2020 |
| K182593 | apex biotechnology | KET-1 Blood Ketone Monitoring System | December 18, 2018 |
| K173345 | taidoc technology corporation | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | May 4, 2018 |
| K170463 | i-sens | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitor | April 13, 2018 |
| K170587 | acon laboratories | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips f | July 6, 2017 |
| K060768 | abbott diabetes care | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS | April 21, 2006 |
| K033114 | neo diagnostics | KETOCHECKS | April 26, 2004 |
| K003987 | teco diagnostics | URS-1K (KETONE TESST) | April 26, 2001 |
| K953662 | polymer technology intl | FIRST CHOICE KETONES URINE TEST STRIPS | June 14, 1996 |
| K953680 | polymer technology intl | FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS | June 12, 1996 |
| K912373 | ihara medics u.s | KETO-340 II | July 1, 1991 |
| K911801 | gds technology | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON | July 1, 1991 |
| K910108 | gds diagnostics | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED | March 4, 1991 |
| K903365 | ihara medics u.s | KETOREX SANWA STANDARDS | December 20, 1990 |
| K903366 | ihara medics u.s | KETONE TEST B SANWA STANDARD | November 20, 1990 |
| K903367 | ihara medics u.s | KETONE TEST A SANWA STANDARD | November 20, 1990 |
| K875029 | abbott laboratories | ABBOTT BREATH ACETONE ANALYZER | May 27, 1988 |
| K850368 | sigma chemical | SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV | August 30, 1985 |
| K841715 | kyoto diagnostics | KYOTEST UK URINE TEST REAGENT STRIP | May 31, 1984 |