INVADER MTHFR 1298— 510(k) K100496

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K100496 for INVADER MTHFR 1298, Substantially Equivalent on 2011-04-25. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code OMM
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Date received: 2010-02-22
Decision date: 2011-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malborough, MA, US

Download summary PDF View on FDA.gov ↗

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