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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K983212
Device Name ABBOTT ARCHITECT TESTOSTERONE
Applicant
ABBOTT LABORATORIES
100/200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact KAREN L GATES
Correspondent
ABBOTT LABORATORIES
100/200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact KAREN L GATES
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Codes
JIS   JJE   JJX  
Date Received09/14/1998
Decision Date 11/18/1998
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
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