Cleared Special

STA LIATEST FREE PS

K092170 · Diagnostica Stago, Inc. · Hematology
Dec 2009
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K092170 is an FDA 510(k) clearance for the STA LIATEST FREE PS, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on December 22, 2009, 154 days after receiving the submission on July 21, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K092170 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2009
Decision Date December 22, 2009
Days to Decision 154 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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