510(k) K100987— INVADER MTHFR 677

Substantially Equivalent

Hologic, Inc.

Clearance details

Applicant: Hologic, Inc.
Product code: Code OMM
Advisory panel: Hematology
Date received: 2010-04-09
Decision date: 2011-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malborough, MA, US

Download summary PDF View on FDA.gov ↗

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