APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS— 510(k) K061377

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K061377 for APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS, Substantially Equivalent on 2007-03-28. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant
Pointe Scientific, Inc.,
Product code
Code MSJ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lincoln Park, MI, US
Download summary PDFView on FDA.gov ↗

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