AMNISTAT-FLM
Device Facts
| Record ID | K822150 |
|---|---|
| Device Name | AMNISTAT-FLM |
| Applicant | Hana Biologics, Inc. |
| Product Code | JHG · Clinical Chemistry |
| Decision Date | Oct 21, 1982 |
| 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.
