CARE FECAL OCCULT BLOOD TEST, MODEL KT313— 510(k) K051806

Name: FDA 510(k) clearance K051806
Creator: U.S. Food and Drug Administration
Published: 2005-10-03

Substantially Equivalent

Epitope Diagnostics, Inc.

FDA 510(k) clearance K051806 for CARE FECAL OCCULT BLOOD TEST, MODEL KT313, Substantially Equivalent on 2005-10-03. Applicant: Epitope Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Epitope Diagnostics, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2005-07-05
Decision date: 2005-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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