CBC PLT-4— 510(k) K802265

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K802265 for CBC PLT-4, Substantially Equivalent on 1980-11-12. 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: 1980-09-16
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.