Cleared Traditional

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

K090236 · Siemens Healthcare Diagnostics · Immunology
Apr 2009
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K090236 is an FDA 510(k) clearance for the DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454, a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 27, 2009, 84 days after receiving the submission on February 2, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K090236 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2009
Decision Date April 27, 2009
Days to Decision 84 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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