INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE— 510(k) K063673

Name: FDA 510(k) clearance K063673
Creator: U.S. Food and Drug Administration
Published: 2007-03-05

Substantially Equivalent

Innovacon, Inc.

FDA 510(k) clearance K063673 for INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE, Substantially Equivalent on 2007-03-05. Applicant: Innovacon, Inc.. Device class: 2.

Clearance details

Applicant: Innovacon, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2006-12-11
Decision date: 2007-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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