Cleared Traditional

FACTOR II (PROTHROMBIN) G20210A KIT

K033612 · Roche Diagnostics Corp. · Pathology

Dec 2003

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K033612 is an FDA 510(k) clearance for the FACTOR II (PROTHROMBIN) G20210A KIT, a Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (Class II — Special Controls, product code NPR), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on December 18, 2003, 31 days after receiving the submission on November 17, 2003. This device falls under the Pathology review panel. Regulated under 21 CFR 864.7280.

Submission Details

510(k) Number	K033612 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2003
Decision Date	December 18, 2003
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.7280
Definition	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.