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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic Separation, Lecithin/Sphingomyelin Ratio
510(k) Number K871593
Device Name TDXR FETAL LUNG MATURITY
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact MARY ZORC
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact MARY ZORC
Regulation Number862.1455
Classification Product Code
JHG  
Date Received04/24/1987
Decision Date 07/20/1987
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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