Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer— 510(k) K223635

Name: FDA 510(k) clearance K223635
Creator: U.S. Food and Drug Administration
Published: 2023-01-04

Substantially Equivalent

Sienco, Inc.

FDA 510(k) clearance K223635 for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer, Substantially Equivalent on 2023-01-04. Applicant: Sienco, Inc.. Device class: 2.

Clearance details

Applicant: Sienco, Inc.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
Advisory panel: Hematology
Date received: 2022-12-05
Decision date: 2023-01-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sienco, Inc.

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K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION2000-08-31
K984141 — GBACT + KIT1999-05-28
K952560 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER1995-09-05

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