ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33


Device Classification Name

enzyme immunoassay, phenobarbital

510(k) Number K081231
Device Name ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
Applicant
ABBOTT LABORATORIES
100 abbott park rd.
dept. 049d bldg. ap 6c-2
abbott park, 
IL 
60064 -6092

Applicant Contact carol jochum
Correspondent
ABBOTT LABORATORIES
100 abbott park rd.
dept. 049d bldg. ap 6c-2
abbott park, 
IL 
60064 -6092

Correspodent Contact carol jochum
Regulation Number 862.3660
Classification Product Code
DLZ  
Subsequent Product Code
DLJ  
Date Received 05/01/2008
Decision Date 09/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No