JHG
7 FDA 510(k) clearances · Product code
87 daysmedian time to decision
163 days90th percentile
7clearances measured
FDA profile
- Official device name
- Chromatographic Separation, 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)
- 1995: 1
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 |
|---|---|---|
| AMNIOSTAT-FLM-PG (K061549) | Irvine Scientific Sales Co., Inc. | 2006-10-18 |
| TDXR FETAL LUNG MATURITY (K871593) | Abbott Laboratories | 1987-07-20 |
| AMNIO STAT-FLM AGGLUTINATION TEST (K834616) | Hana Biologics, Inc. | 1984-05-25 |
| AMNISTAT-FLM (K822150) | Hana Biologics, Inc. | 1982-10-21 |
| SECURE FDI TEST KIT (K813216) | Beckman Instruments, Inc. | 1981-12-17 |
| HELENA FETAL-TEK 200 METHOD (K811588) | Helena Laboratories | 1981-06-25 |
| FETAL MATURITY TEST PROCEDURE (K790798) | Helena Laboratories | 1979-06-05 |
Track JHG automatically
Every clearance here is in the API, with alerts when new ones post.