Cleared Traditional

STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER

K082248 · Diagnostica Stago, Inc. · Hematology
Dec 2008
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K082248 is an FDA 510(k) clearance for the STA SATELLITE AUTOMATED MULTI-PARAMETER 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 12, 2008, 126 days after receiving the submission on August 8, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K082248 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2008
Decision Date December 12, 2008
Days to Decision 126 days
Submission Type Traditional
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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