510(k) K002199— MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

Substantially Equivalent

Pointe Scientific, Inc.,

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 2000-07-20
Decision date: 2000-11-20
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.