CELL-DYN 400 HEMOTOLOGY ANALYZER— 510(k) K831368

Name: FDA 510(k) clearance K831368
Creator: U.S. Food and Drug Administration
Published: 1983-07-18

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K831368 for CELL-DYN 400 HEMOTOLOGY ANALYZER, Substantially Equivalent on 1983-07-18. Applicant: Abbott Diagnostics. Device class: 2.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1983-04-26
Decision date: 1983-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.