CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE— 510(k) K890749

Name: FDA 510(k) clearance K890749
Creator: U.S. Food and Drug Administration
Published: 1989-02-27

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K890749 for CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE, Substantially Equivalent on 1989-02-27. 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: 1989-02-13
Decision date: 1989-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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