PACKS-4 (TM) ANALYZER— 510(k) K912201

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K912201 for PACKS-4 (TM) ANALYZER, Substantially Equivalent on 1991-08-16. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JBY
Advisory panel: Hematology
Date received: 1991-05-20
Decision date: 1991-08-16
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.