CARDIOMPO TEST


Device Classification Name

myeloperoxidase, immunoassay, system, test

510(k) Number K050029
Device Name CARDIOMPO TEST
Applicant
PROGNOSTIX, INC.
10265 carnegie avenue
cleveland, 
OH 
44106

Applicant Contact thomas m jackson
Correspondent
PROGNOSTIX, INC.
10265 carnegie avenue
cleveland, 
OH 
44106

Correspodent Contact thomas m jackson
Regulation Number 866.5600
Classification Product Code
NTV  
Subsequent Product Codes
JIS   JJX  
Date Received 01/06/2005
Decision Date 05/10/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No