PATHFAST CK-MB-II, PATHFAST MYO-II


Device Classification Name

fluorometric method, cpk or isoenzymes

510(k) Number K081360
Device Name PATHFAST CK-MB-II, PATHFAST MYO-II
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 862.1215
Classification Product Code
JHX  
Subsequent Product Codes
DDR   JIT  
Date Received 05/15/2008
Decision Date 08/17/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No