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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 K813216
Device Name SECURE FDI TEST KIT
Applicant
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Beckman Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1455
Classification Product Code
JHG  
Date Received11/09/1981
Decision Date 12/17/1981
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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