CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED— 510(k) K904464

Name: FDA 510(k) clearance K904464
Creator: U.S. Food and Drug Administration
Published: 1990-10-23

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K904464 for CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED, Substantially Equivalent on 1990-10-23. 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: 1990-10-01
Decision date: 1990-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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