RANDOX PHENOBARBITAL


Device Classification Name

enzyme immunoassay, phenobarbital

510(k) Number K011303
Device Name RANDOX PHENOBARBITAL
Original Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, co. antrim, 

IE

bt29 4qy

Original Contact pauline armstrong
Regulation Number 862.3660
Classification Product Code
DLZ  
Date Received 04/30/2001
Decision Date 07/02/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized