PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL


Device Classification Name

enzyme immunoassay, propoxyphene

510(k) Number K111363
Device Name PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
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 862.3700
Classification Product Code
JXN  
Subsequent Product Codes
DLJ   LAS  
Date Received 05/16/2011
Decision Date 12/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No