HANDHELD BASE UNIT


Device Classification Name

test, time, prothrombin

510(k) Number K072920
Device Name HANDHELD BASE UNIT
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact jason fisher
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact jason fisher
Regulation Number 864.7750
Classification Product Code
GJS  
Date Received 10/15/2007
Decision Date 01/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No