ABBOTT ARCHITECT FOLATE


Device Classification Name

acid, folic, radioimmunoassay

510(k) Number K023397
Device Name ABBOTT ARCHITECT FOLATE
Original Applicant
ABBOTT LABORATORIES
200 abbott park rd.
abbott park, 
IL 
60064 -6187

Original Contact margaret prochniak
Regulation Number 862.1295
Classification Product Code
CGN  
Subsequent Product Codes
JIS   JJX  
Date Received 10/09/2002
Decision Date 12/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls