OCCULTECH FECAL OCCULT BLOOD RAPID TEST— 510(k) K060953

Name: FDA 510(k) clearance K060953
Creator: U.S. Food and Drug Administration
Published: 2006-09-18

Substantially Equivalent

Yd Diagnostics Corp.

FDA 510(k) clearance K060953 for OCCULTECH FECAL OCCULT BLOOD RAPID TEST, Substantially Equivalent on 2006-09-18. Applicant: Yd Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Yd Diagnostics Corp.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2006-04-06
Decision date: 2006-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annandale, VA, US

Download summary PDF View on FDA.gov ↗

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