Cleared Traditional

DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL

K121122 · Biochemical Diagnostic, Inc. · Chemistry
Jul 2012
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K121122 is an FDA 510(k) clearance for the DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by Biochemical Diagnostic, Inc. (Edgewood, US). The FDA issued a Cleared decision on July 3, 2012, 81 days after receiving the submission on April 13, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K121122 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2012
Decision Date July 03, 2012
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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