Cleared Traditional

EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE

K093297 · Epocal, Inc. · Chemistry
Jun 2010
Decision
231d
Days
Class 1
Risk

About This 510(k) Submission

K093297 is an FDA 510(k) clearance for the EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE, a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on June 9, 2010, 231 days after receiving the submission on October 21, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.

Submission Details

510(k) Number K093297 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2009
Decision Date June 09, 2010
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHP — Acid, Lactic, Enzymatic Method
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1450

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