FACTOR V LEIDEN KIT— 510(k) DEN030005

Unknown

Roche Diagnostics Corp.

FDA 510(k) clearance DEN030005 for FACTOR V LEIDEN KIT, Unknown on 2003-12-17. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code NPQ
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Date received: 2003-12-08
Decision date: 2003-12-17
Decision: Unknown
Clearance type: Post-NSE
Location: Indianapolis, IN, US

View on FDA.gov ↗

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