KET-1 Blood Ketone Monitoring System
FDA 510(k) K182593 · Apex BioTechnology Corp.
510(k) numberK182593
Submission
- Device name
- KET-1 Blood Ketone Monitoring System
- Applicant
- Apex BioTechnology Corp.
Hsinchu, TW - Received
- September 20, 2018
- Decision date
- December 18, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIN – Nitroprusside, Ketones (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1435
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201551 | KetoSens BT Blood B-Ketone Monitoring SystemJIN · Special | I-Sens, Inc. | 09/09/2020SE |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring SystemJIN · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/05/2020SE |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemJIN · Traditional | Taidoc Technology Corporation | 05/04/2018SE |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN · Traditional | I-Sens, Inc. | 04/13/2018SE |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for…JIN · Traditional | ACON Laboratories, Inc. | 07/06/2017SE |
| K060768 | Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsJIN · Special | Abbott Diabetes Care, Inc. | 04/21/2006SE |
| K033114 | KetochecksJIN · Traditional | Neo Diagnostics, Inc. | 04/26/2004SE |
| K003987 | URS-1K (Ketone Tesst)JIN · Traditional | Teco Diagnostics | 04/26/2001SE |
| K953662 | First Choice Ketones Urine Test StripsJIN · Traditional | Polymer Technology Intl. | 06/14/1996SE |
| K953680 | First Choice Glucose & Ketones Urine Test StripsJIN · Traditional | Polymer Technology Intl. | 06/12/1996SE |
More from Polymer Technology Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring SystemPTC · Traditional | 04/04/2025SE |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring SystemNBW · Special | 12/21/2022SE |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemNBW · Special | 11/04/2022SE |
| K212140 | GlucoSure Link Blood Glucose Monitoring SystemNBW · Traditional | 08/25/2022SE |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 04/06/2022SE |
| K213887 | GAL-1A Plus Blood Glucose Monitoring SystemNBW · Special | 03/29/2022SE |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 10/15/2021SE |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring SystemNBW · Special | 09/15/2021SE |
| K182992 | BGM014 Blood Glucose Monitoring SystemNBW · Special | 11/28/2018SE |
| K170267 | BGM009 Plus Blood Glucose Monitoring SystemNBW · Special | 03/09/2017SE |
Questions and answers
When was KET-1 Blood Ketone Monitoring System cleared by the FDA?
KET-1 Blood Ketone Monitoring System (K182593) received a 510(k) decision of Substantially Equivalent on December 18, 2018, 89 days after the submission was received.
What is the product code of K182593?
The FDA product code is JIN – Nitroprusside, Ketones (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1435.