RANDOX EVIDENCE


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K030360
Device Name RANDOX EVIDENCE
Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim, 

GB

bt29 4qy

Applicant Contact pauline armstrong
Correspondent
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim, 

GB

bt29 4qy

Correspodent Contact pauline armstrong
Regulation Number 862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DLJ   JJE  
Date Received 02/03/2003
Decision Date 12/23/2003
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