First Choice Ketones Urine Test Strips
FDA 510(k) K953662 · Polymer Technology Intl.
510(k) numberK953662
Submission
- Device name
- First Choice Ketones Urine Test Strips
- Applicant
- Polymer Technology Intl.
Issaquah, WA, US - Received
- August 7, 1995
- Decision date
- June 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K182593 | KET-1 Blood Ketone Monitoring SystemJIN · Traditional | Apex BioTechnology Corp. | 12/18/2018SE |
| 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 |
| K953680 | First Choice Glucose & Ketones Urine Test StripsJIN · Traditional | Polymer Technology Intl. | 06/12/1996SE |
More from Polymer Technology Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K953672 | First Choice Urinary Tract Infection Test StripsJMT · Traditional | 07/01/1996SE |
| K953661 | First Choice Glucose Urine Test StripsJIL · Traditional | 06/14/1996SE |
| K953680 | First Choice Glucose & Ketones Urine Test StripsJIN · Traditional | 06/12/1996SE |
| K950628 | First Choice Test StripCGA · Traditional | 11/08/1995SE |
| K946166 | First Choice(Tm) Test StripCGA · Traditional | 11/08/1995SE |
Questions and answers
When was First Choice Ketones Urine Test Strips cleared by the FDA?
First Choice Ketones Urine Test Strips (K953662) received a 510(k) decision of Substantially Equivalent on June 14, 1996, 312 days after the submission was received.
What is the product code of K953662?
The FDA product code is JIN – Nitroprusside, Ketones (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1435.