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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Lecithin/Sphingomyelin Ratio
510(k) Number K940817
Device Name TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II
Applicant
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact Irene Powers
Correspondent
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact Irene Powers
Regulation Number862.1455
Classification Product Code
JHF  
Date Received02/22/1994
Decision Date 02/08/1995
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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