The following data is part of a premarket notification filed by Polymer Technology Intl. with the FDA for First Choice Urinary Tract Infection Test Strips.
| Device ID | K953672 |
| 510k Number | K953672 |
| Device Name: | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS |
| Classification | Diazo (colorimetric), Nitrite (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 | JMT |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1996-07-01 |