510(k) K953680

FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS by Polymer Technology Intl. — Product Code JIN

K953680 is an FDA 510(k) premarket notification submitted by Polymer Technology Intl. for the device "FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS". The FDA issued a decision of Substantially Equivalent on June 12, 1996. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. Polymer Technology Intl. has at least 5 other 510(k) clearances on record.