RANDOX AMIKACIN

Device Classification Name

radioimmunoassay, amikacin

510(k) Number K033884
Device Name RANDOX AMIKACIN
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 862.3035
Classification Product Code
KLQ  
Date Received 12/15/2003
Decision Date 06/09/2004
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