FACTOR V LEIDEN KIT


Device Classification Name

test, factor v leiden mutations, genomic dna pcr

510(k) Number DEN030005
Device Name FACTOR V LEIDEN KIT
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Original Contact robert a gregg
Regulation Number 864.7280
Classification Product Code
NPQ  
Date Received 12/08/2003
Decision Date 12/17/2003
Decision

an

(AN)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

Type Post-NSE

Reviewed by Third Party No

Combination Product

No