Cleared Traditional

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER

K092849 · Epocal, Inc. · Chemistry
Mar 2010
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K092849 is an FDA 510(k) clearance for the BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on March 30, 2010, 195 days after receiving the submission on September 16, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K092849 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2009
Decision Date March 30, 2010
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEM — Electrode, Ion Specific, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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