MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL— 510(k) K860028

Name: FDA 510(k) clearance K860028
Creator: U.S. Food and Drug Administration
Published: 1986-04-07

Substantially Equivalent

Self Care Systems, Inc.

FDA 510(k) clearance K860028 for MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL, Substantially Equivalent on 1986-04-07. Applicant: Self Care Systems, Inc.. Device class: 2.

Clearance details

Applicant: Self Care Systems, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1986-01-03
Decision date: 1986-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.