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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 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Sienco, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032952AIACT KITK002528SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONK984141GBACT + KITK952560SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER

Related Devices (Code: JBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.K032952AIACT KITSienco, Inc.K023582I-STAT KAOLIN ACT TESTI-Stat CorporationK020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena LaboratoriesK013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena LaboratoriesK002528SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONSienco, Inc.

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.

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