INVADER FACTOR V— 510(k) K100980

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K100980 for INVADER FACTOR V, Substantially Equivalent on 2011-06-01. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant
Hologic, Inc.
Product code
Code NPQ
Device class
Class 2
Regulation
21 CFR 864.7280
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Malborough, MA, US
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