510(k) K953662
- Device
- FIRST CHOICE KETONES URINE TEST STRIPS
- Applicant
- POLYMER TECHNOLOGY INTL.
- 510(k) number
- K953662
- Product code
- JIN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-14
- Date received
- 1995-08-07
- Regulation
- 862.1435
- Classification name
- Nitroprusside, Ketones (urinary, Non-quant.)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Clearance type
- Traditional
- Third party reviewed
- No
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 |
| 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 |
Legacy Summary#
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FDA Review#
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