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FDA 510(k)

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

K-Number: K162540 · 2017-08-22

ApplicantSiemens Healthcare Diagnostics Prodcts GmbH
Decision Date2017-08-22
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls is a medical device manufactured by Siemens Healthcare Diagnostics Prodcts GmbH. It received FDA 510(k) clearance on 2017-08-22 under approval number K162540. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls?

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls is a medical device that received FDA 510(k) clearance on 2017-08-22. It is manufactured by Siemens Healthcare Diagnostics Prodcts GmbH. The 510(k) number is K162540.

When was INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls approved by the FDA?

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls received FDA 510(k) clearance on 2017-08-22, under approval number K162540.

What company makes INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls?

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls is manufactured by Siemens Healthcare Diagnostics Prodcts GmbH.

What is the FDA product code for INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls?

The FDA product code for INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls is KFF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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