Cleared Traditional

SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ

K132688 · Biochemical Diagnostics, Inc. · Toxicology
Dec 2013
Decision
110d
Days
Class 1
Risk

About This 510(k) Submission

K132688 is an FDA 510(k) clearance for the SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Biochemical Diagnostics, Inc. (Edgewood, US). The FDA issued a Cleared decision on December 16, 2013, 110 days after receiving the submission on August 28, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K132688 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2013
Decision Date December 16, 2013
Days to Decision 110 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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