FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25— 510(k) K061065

Name: FDA 510(k) clearance K061065
Creator: U.S. Food and Drug Administration
Published: 2006-07-14

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K061065 for FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25, Substantially Equivalent on 2006-07-14. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2006-04-17
Decision date: 2006-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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