SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION— 510(k) K002528

Name: FDA 510(k) clearance K002528
Creator: U.S. Food and Drug Administration
Published: 2000-08-31

Substantially Equivalent

Sienco, Inc.

FDA 510(k) clearance K002528 for SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION, Substantially Equivalent on 2000-08-31. 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: 2000-08-16
Decision date: 2000-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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