ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL


Device Classification Name

alcohol dehydrogenase, specific reagent for ethanol enzyme method

510(k) Number K111005
Device Name ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL 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 862.3040
Classification Product Code
DIC  
Subsequent Product Codes
DLJ   LAS  
Date Received 04/11/2011
Decision Date 11/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No