IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10— 510(k) K100031

Name: FDA 510(k) clearance K100031
Creator: U.S. Food and Drug Administration
Published: 2010-07-19

Substantially Equivalent

Ind Diagnostic, Inc.

FDA 510(k) clearance K100031 for IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10, Substantially Equivalent on 2010-07-19. Applicant: Ind Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Ind Diagnostic, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2010-01-06
Decision date: 2010-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, B.C., CA

Download summary PDF View on FDA.gov ↗

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