K020625

Substantially Equivalent

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346

Applicant: Helena Laboratories
Product code: CIN
Advisory panel: Clinical Chemistry
Date received: 2002-02-26
Decision date: 2002-05-06
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.