510(k) K911792

FIRST CHOICE(TM), MODIFICATION by Polymer Technology Corp. — Product Code CGA

K911792 is an FDA 510(k) premarket notification submitted by Polymer Technology Corp. for the device "FIRST CHOICE(TM), MODIFICATION". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Polymer Technology Corp. has at least 10 other 510(k) clearances on record.