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510(k) K871593

TDXR FETAL LUNG MATURITY by Abbott Laboratories — Product Code JHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1987
Date Received
April 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Device Class
Class II
Regulation Number
862.1455
Review Panel
CH
Submission Type

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