HELENA FETAL-TEK 200 METHOD
Device Facts
| Record ID | K811588 |
|---|---|
| Device Name | HELENA FETAL-TEK 200 METHOD |
| Applicant | Helena Laboratories |
| Product Code | JHG · Clinical Chemistry |
| Decision Date | Jun 25, 1981 |
| 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.
