Cleared Traditional

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls

K162540 · Siemens Healthcare Diagnostics Prodcts GmbH · Hematology

Aug 2017

Decision

344d

Days

Class 2

Risk

About This 510(k) Submission

K162540 is an FDA 510(k) clearance for the INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by Siemens Healthcare Diagnostics Prodcts GmbH (Marburg, DE). The FDA issued a Cleared decision on August 22, 2017, 344 days after receiving the submission on September 12, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number	K162540 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 2016
Decision Date	August 22, 2017
Days to Decision	344 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF