510(k) K163436

Greiner Vacuette Urine Count and Culture, Mannitol tube by Greiner Bio-One Na, Inc. — Product Code JSM

K163436 is an FDA 510(k) premarket notification submitted by Greiner Bio-One Na, Inc. for the device "Greiner Vacuette Urine Count and Culture, Mannitol tube". The FDA issued a decision of Substantially Equivalent on Mar 6, 2017. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Greiner Bio-One Na, Inc. has 4 other 510(k) clearances on record.