TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II
Device Facts
| Record ID | K940817 |
|---|---|
| Device Name | TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II |
| Applicant | Abbott Laboratories |
| Product Code | JHF · Clinical Chemistry |
| Decision Date | Feb 8, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1455 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.
