CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM— 510(k) DEN040001

Name: FDA 510(k) clearance DEN040001
Creator: U.S. Food and Drug Administration
Published: 2004-01-21

Unknown

Advanced Diagnostic Systems

FDA 510(k) clearance DEN040001 for CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM, Unknown on 2004-01-21. Applicant: Advanced Diagnostic Systems. Device class: 2.

Clearance details

Applicant: Advanced Diagnostic Systems
Product code: Code NQI
Device class: Class 2
Regulation: 21 CFR 866.6020
Advisory panel: Immunology
Date received: 2004-01-02
Decision date: 2004-01-21
Decision: Unknown
Clearance type: Post-NSE
Location: Raritan, NJ, US

View on FDA.gov ↗

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