K100716

Substantially Equivalent

AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

Applicant: Aalto Scientific, Ltd.
Product code: GGN
Advisory panel: Hematology
Date received: 2010-03-12
Decision date: 2011-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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