IMMUNE CELL FUNCTION ASSAY— 510(k) K013169

Substantially Equivalent

Cylex, Inc.

FDA 510(k) clearance K013169 for IMMUNE CELL FUNCTION ASSAY, Substantially Equivalent on 2002-04-02. Applicant: Cylex, Inc.. Device class: 2.

Clearance details

Applicant
Cylex, Inc.
Product code
Code NID
Device class
Class 2
Regulation
21 CFR 864.5220
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Baldwin, MD, US
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