EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE— 510(k) K093297

Name: FDA 510(k) clearance K093297
Creator: U.S. Food and Drug Administration
Published: 2010-06-09

Substantially Equivalent

Epocal, Inc.

FDA 510(k) clearance K093297 for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE, Substantially Equivalent on 2010-06-09. Applicant: Epocal, Inc.. Device class: 1.

Clearance details

Applicant: Epocal, Inc.
Product code: Code KHP
Device class: Class 1
Regulation: 21 CFR 862.1450
Advisory panel: Clinical Chemistry
Date received: 2009-10-21
Decision date: 2010-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

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Recalls naming K093297

K-number listed on FDA's recall record

Z-1971-2013 — epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.Class II·Terminated·Epocal·20130313

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093297.

Data sourced from openFDA. This site is unofficial and independent of the FDA.