AIACT KIT— 510(k) K032952

Substantially Equivalent

Sienco, Inc.

FDA 510(k) clearance K032952 for AIACT KIT, Substantially Equivalent on 2003-12-12. 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: 2003-09-22
Decision date: 2003-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.