K061377

Substantially Equivalent

APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

Applicant: Pointe Scientific, Inc.,
Product code: MSJ
Advisory panel: Clinical Chemistry
Date received: 2006-05-17
Decision date: 2007-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.