COLOSCREEN— 510(k) K911075

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K911075 for COLOSCREEN, Substantially Equivalent on 1991-07-03. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code KHE
Advisory panel: Hematology
Date received: 1991-03-11
Decision date: 1991-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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