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

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..

Clearance details

Applicant: Self Care Systems, Inc.
Product code: Code KHE
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 ↗

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