PATHFAST NTPROBNP AND D-DIMER TESTS


Device Classification Name

test,natriuretic peptide

510(k) Number K072189
Device Name PATHFAST NTPROBNP AND D-DIMER TESTS
Applicant
MITSUBISHI KAGAKU IATRON
701 fifth avenue
floor 42
seattle, 
WA 
98104

Applicant Contact helen landicho
Correspondent
MITSUBISHI KAGAKU IATRON
701 fifth avenue
floor 42
seattle, 
WA 
98104

Correspodent Contact helen landicho
Regulation Number 862.1117
Classification Product Code
NBC  
Date Received 08/06/2007
Decision Date 02/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No