CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04— 510(k) K072096

Name: FDA 510(k) clearance K072096
Creator: U.S. Food and Drug Administration
Published: 2007-08-20

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K072096 for CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04, Substantially Equivalent on 2007-08-20. 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: 2007-07-31
Decision date: 2007-08-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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