EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT


Device Classification Name

catalytic methods, amylase

510(k) Number K080823
Device Name EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
Applicant
MEDICA CORP.
5 oak park drive
bedford, 
MA 
01730

Applicant Contact photios makris
Correspondent
MEDICA CORP.
5 oak park drive
bedford, 
MA 
01730

Correspodent Contact photios makris
Regulation Number 862.1070
Classification Product Code
JFJ  
Subsequent Product Codes
CDQ   CDT   CFR   KNK  
Date Received 03/24/2008
Decision Date 11/17/2008
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