Cleared Special

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

K093167 · Diagnostica Stago, Inc. · Hematology
Dec 2009
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K093167 is an FDA 510(k) clearance for the STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on December 22, 2009, 76 days after receiving the submission on October 7, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K093167 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2009
Decision Date December 22, 2009
Days to Decision 76 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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