JHF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Colorimetric Method, Lecithin/Sphingomyelin Ratio
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1455
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II (K940817) | Abbott Laboratories | 1995-02-08 |
| PG-NUMERIC(TM) (K883411) | Isolab, Inc. | 1989-03-15 |
Track JHF automatically
Every clearance here is in the API, with alerts when new ones post.