PICOSCAL BLOOD CELL COUNTER PS-4— 510(k) K842140

Name: FDA 510(k) clearance K842140
Creator: U.S. Food and Drug Administration
Published: 1984-08-16

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K842140 for PICOSCAL BLOOD CELL COUNTER PS-4, Substantially Equivalent on 1984-08-16. Applicant: Diagnostic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1984-05-30
Decision date: 1984-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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