510(k) K223046

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

February 15, 2023

Date Received

September 29, 2022

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Device Class

Class II

Regulation Number

864.7280

Review Panel

PA

Submission Type

In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.