CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518— 510(k) K022512

Name: FDA 510(k) clearance K022512
Creator: U.S. Food and Drug Administration
Published: 2002-09-30

Substantially Equivalent

Immunicon Corp.

FDA 510(k) clearance K022512 for CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518, Substantially Equivalent on 2002-09-30. Applicant: Immunicon Corp.. Device class: 1.

Clearance details

Applicant: Immunicon Corp.
Product code: Code GKH
Device class: Class 1
Regulation: 21 CFR 864.5240
Advisory panel: Hematology
Date received: 2002-07-30
Decision date: 2002-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntingdon Valley, PA, US

Download summary PDF View on FDA.gov ↗

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