EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE— 510(k) K852391

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K852391 for EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE, Substantially Equivalent on 1985-10-01. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CFH
Advisory panel: Clinical Chemistry
Date received: 1985-06-05
Decision date: 1985-10-01
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.