Cleared Traditional

DC-UIBC-CO2-CAL, MODEL SE-153

K013178 · Diagnostic Chemicals , Ltd. · Chemistry
Dec 2001
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K013178 is an FDA 510(k) clearance for the DC-UIBC-CO2-CAL, MODEL SE-153, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on December 18, 2001, 85 days after receiving the submission on September 24, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K013178 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2001
Decision Date December 18, 2001
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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