510(k) K132688

SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ by Biochemical Diagnostics, Inc. — Product Code DIF

K132688 is an FDA 510(k) premarket notification submitted by Biochemical Diagnostics, Inc. for the device "SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ". The FDA issued a decision of Substantially Equivalent on December 16, 2013. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Biochemical Diagnostics, Inc. has at least 1 other 510(k) clearance on record.