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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K023397
Device Name ABBOTT ARCHITECT FOLATE
Applicant
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6187
Applicant Contact MARGARET PROCHNIAK
Correspondent
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6187
Correspondent Contact MARGARET PROCHNIAK
Regulation Number862.1295
Classification Product Code
CGN  
Subsequent Product Codes
JIS   JJX  
Date Received10/09/2002
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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