510(k) K964698

SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT by Andwin Scientific — Product Code JKA

K964698 is an FDA 510(k) premarket notification submitted by Andwin Scientific for the device "SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT". The FDA issued a decision of Substantially Equivalent on March 3, 1997. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Andwin Scientific has at least 2 other 510(k) clearances on record.