Cleared Traditional

STA R Max 3, STA Compact Max 3

K212183 · Diagnostica Stago S.A.S · Hematology
Jun 2023
Decision
694d
Days
Class 2
Risk

About This 510(k) Submission

K212183 is an FDA 510(k) clearance for the STA R Max 3, STA Compact Max 3, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Diagnostica Stago S.A.S (Asni?res Sur Seine, FR). The FDA issued a Cleared decision on June 7, 2023, 694 days after receiving the submission on July 13, 2021. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K212183 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2021
Decision Date June 07, 2023
Days to Decision 694 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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