Cleared Special

STA R MAX

K151867 · Diagnostica Stago S.A.S · Hematology
Aug 2015
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K151867 is an FDA 510(k) clearance for the STA R MAX, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Diagnostica Stago S.A.S (Gennevilliers, FR). The FDA issued a Cleared decision on August 7, 2015, 29 days after receiving the submission on July 9, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K151867 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2015
Decision Date August 07, 2015
Days to Decision 29 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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