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 |