Cleared Traditional

INNOVANCE Antithrombin

K242952 · Siemens Healthcare Diagnostic Products GmbH · Hematology
Mar 2025
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K242952 is an FDA 510(k) clearance for the INNOVANCE Antithrombin, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Siemens Healthcare Diagnostic Products GmbH (Marburg, DE). The FDA issued a Cleared decision on March 28, 2025, 184 days after receiving the submission on September 25, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K242952 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2024
Decision Date March 28, 2025
Days to Decision 184 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBQ — Antithrombin Iii Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7060

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