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510(k) K162540

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls by Siemens Healthcare Diagnostics Prodcts GmbH — Product Code KFF

K162540 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Prodcts GmbH for the device "INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls". The FDA issued a decision of Substantially Equivalent on August 22, 2017. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2017
Date Received
September 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

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  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
  • K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (June 2, 2009)
  • K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (May 24, 2006)
  • K013305 — ENOXAPARIN TEST CARD (August 23, 2002)
  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
  • K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (March 8, 2002)
  • K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (June 7, 2001)
  • K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (June 6, 2001)
  • K983178 — COAMATIC HEPARIN (November 3, 1998)

FDA data resources