IND ONE STEP OCCULT BLOOD (FOB) TEST— 510(k) K113506

Name: FDA 510(k) clearance K113506
Creator: U.S. Food and Drug Administration
Published: 2012-12-19

Substantially Equivalent

Ind Diagnostics, Inc.

FDA 510(k) clearance K113506 for IND ONE STEP OCCULT BLOOD (FOB) TEST, Substantially Equivalent on 2012-12-19. Applicant: Ind Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ind Diagnostics, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2011-11-28
Decision date: 2012-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Delta, B.C., CA

Download summary PDF View on FDA.gov ↗

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