GENESIS I AUTOMATED CELL COUNTER— 510(k) K910679

Name: FDA 510(k) clearance K910679
Creator: U.S. Food and Drug Administration
Published: 1991-05-07

Substantially Equivalent

Alicia Diagnostics, Inc.

FDA 510(k) clearance K910679 for GENESIS I AUTOMATED CELL COUNTER, Substantially Equivalent on 1991-05-07. Applicant: Alicia Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Alicia Diagnostics, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1991-02-15
Decision date: 1991-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oviedo, FL, US

Download summary PDF View on FDA.gov ↗

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