COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581— 510(k) K901414

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K901414 for COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581, Substantially Equivalent on 1990-06-15. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code LCP
Advisory panel: Hematology
Date received: 1990-03-26
Decision date: 1990-06-15
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.