The following data is part of a premarket notification filed by Polymer Technology Intl. with the FDA for First Choice Ketones Urine Test Strips.
| Device ID | K953662 |
| 510k Number | K953662 |
| Device Name: | FIRST CHOICE KETONES URINE TEST STRIPS |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | POLYMER TECHNOLOGY INTL. 1871 N.W. GILMAN BLVD. Issaquah, WA 98027 |
| Contact | Estela Figueroa |
| Correspondent | Estela Figueroa POLYMER TECHNOLOGY INTL. 1871 N.W. GILMAN BLVD. Issaquah, WA 98027 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1996-06-14 |