510(k) K121053

DIAZYME HOMOCYSTEINE POC TEST KIT by Diazyme Laboratories — Product Code LPS

K121053 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME HOMOCYSTEINE POC TEST KIT". The FDA issued a decision of Substantially Equivalent on July 31, 2012. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Diazyme Laboratories has at least 10 other 510(k) clearances on record.