IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K080057
Device Name IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
Applicant
NOVX SYSTEMS INC.
16809 briardale road
rockville, 
MD 
20853

Applicant Contact thomas tsakeris
Correspondent
NOVX SYSTEMS INC.
16809 briardale road
rockville, 
MD 
20853

Correspodent Contact thomas tsakeris
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIF   DJG   DLJ   LCM   LDJ  
Date Received 01/09/2008
Decision Date 10/31/2008
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