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 the device name listed in this FDA 510(k) record. The listed applicant is Sienco, Inc.. It received FDA 510(k) clearance on 2023-01-04 under 510(k) 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. The listed applicant is Sienco, Inc.. The 510(k) number is K223635.
When did Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer receive FDA 510(k) clearance?
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer received FDA 510(k) clearance on 2023-01-04, under 510(k) number K223635.
Who is the listed applicant for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer?
The FDA 510(k) record lists Sienco, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.