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FDA 510(k)

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer

K-Number: K223635 · 2023-01-04

ApplicantSienco, Inc.
Decision Date2023-01-04
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer is a medical device manufactured by Sienco, Inc.. It received FDA 510(k) clearance on 2023-01-04 under approval number K223635. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer?

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer is a medical device that received FDA 510(k) clearance on 2023-01-04. It is manufactured by Sienco, Inc.. The 510(k) number is K223635.

When was Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer approved by the FDA?

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer received FDA 510(k) clearance on 2023-01-04, under approval number K223635.

What company makes Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer?

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer is manufactured by Sienco, Inc..

What is the FDA product code for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer?

The FDA product code for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer is JBP.

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Official Source

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