R&D CBC-3D + CRP HEMATOLOGY CONTROL— 510(k) K061511

Name: FDA 510(k) clearance K061511
Creator: U.S. Food and Drug Administration
Published: 2006-07-10

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K061511 for R&D CBC-3D + CRP HEMATOLOGY CONTROL, Substantially Equivalent on 2006-07-10. Applicant: R&D Systems, Inc.. Device class: 2.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2006-06-01
Decision date: 2006-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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