510(k) K170587

On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis by ACON Laboratories, Inc. — Product Code JIN

K170587 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis". The FDA issued a decision of Substantially Equivalent on July 6, 2017. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.