QCA (VERSION 3.1)— 510(k) K031363

Substantially Equivalent

Cell Analysis, Inc.

FDA 510(k) clearance K031363 for QCA (VERSION 3.1), Substantially Equivalent on 2004-02-05. Applicant: Cell Analysis, Inc.. Device class: 2.

Clearance details

Applicant: Cell Analysis, Inc.
Product code: Code NQN
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2003-04-30
Decision date: 2004-02-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Evanston, IL, US

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