ELLAGIC ACID APTT REAGENT— 510(k) K915418

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K915418 for ELLAGIC ACID APTT REAGENT, Substantially Equivalent on 1992-02-14. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code GFO
Advisory panel: Hematology
Date received: 1991-12-02
Decision date: 1992-02-14
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.