ASSIGNED VALUE FOR MEAN PLATELET— 510(k) K841239

Name: FDA 510(k) clearance K841239
Creator: U.S. Food and Drug Administration
Published: 1984-05-02

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K841239 for ASSIGNED VALUE FOR MEAN PLATELET, Substantially Equivalent on 1984-05-02. Applicant: Coulter Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1984-03-23
Decision date: 1984-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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