Home / 510(k) Clearances / K242952

510(k) K242952

INNOVANCE Antithrombin by Siemens Healthcare Diagnostic Products GmbH — Product Code JBQ

K242952 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostic Products GmbH for the device "INNOVANCE Antithrombin". The FDA issued a decision of Substantially Equivalent on March 28, 2025. The device falls under product code JBQ (Antithrombin Iii Quantitation), a Class II device regulated under 21 CFR 864.7060. Siemens Healthcare Diagnostic Products GmbH has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2025
Date Received
September 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antithrombin Iii Quantitation
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

Other clearances by Siemens Healthcare Diagnostic Products GmbH

  • K232624 — CardioPhase® hsCRP (November 27, 2023)
  • K172286 — Automated Blood Coagulation Analyzer CS-2500 (December 18, 2017)
  • K150678 — Sysmex Automated Blood Coagulation Analyzer CS-5100 (January 11, 2016)

Other clearances for product code JBQ

  • K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (May 28, 2009)
  • K070301 — HEMOSIL ANTITHROMBIN (February 23, 2007)
  • K062431 — HEMOSIL LIQUID ANTITHROMBIN (September 1, 2006)
  • K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE (November 7, 2005)
  • K033775 — HEMOSIL LIQUID ANTITHROMBIN XL (January 2, 2004)
  • K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (April 28, 2003)
  • K022550 — COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (August 27, 2002)
  • K022195 — COAMATIC AT-400 (August 7, 2002)
  • K994238 — IL TEST LIQUID ANTITHROMBIN (June 23, 2000)
  • K000361 — K-ASSAY AT-III (April 26, 2000)

FDA data resources