Cleared Traditional

STA- NeoPTimal

K211485 · Diagnostica Stago S.A.S · Hematology
Dec 2022
Decision
589d
Days
Class 2
Risk

About This 510(k) Submission

K211485 is an FDA 510(k) clearance for the STA- NeoPTimal, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Diagnostica Stago S.A.S (Asni?res Sur Seine, FR). The FDA issued a Cleared decision on December 23, 2022, 589 days after receiving the submission on May 13, 2021. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K211485 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2021
Decision Date December 23, 2022
Days to Decision 589 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750