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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nephelometer, For Clinical Use
510(k) Number K851253
Device Name TDX ANALYZER W/NEPHELOMETRY CAROUSEL
Applicant
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015
Applicant Contact BEVERLY G CHAMBERS
Correspondent
Abbott Laboratories
1921 Hurd Dr.
P.O.Box 152020
Irving,  TX  75015
Correspondent Contact BEVERLY G CHAMBERS
Regulation Number862.2700
Classification Product Code
JQX  
Date Received03/28/1985
Decision Date 04/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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