JHG — Chromatographic Separation, Lecithin/Sphingomyelin Ratio Class II
FDA Device Classification
Classification Details
- Product Code
- JHG
- Device Class
- Class II
- Regulation Number
- 862.1455
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K061549 | irvine scientific sales co | AMNIOSTAT-FLM-PG | October 18, 2006 |
| K871593 | abbott laboratories | TDXR FETAL LUNG MATURITY | July 20, 1987 |
| K834616 | hana biologics | AMNIO STAT-FLM AGGLUTINATION TEST | May 25, 1984 |
| K822150 | hana biologics | AMNISTAT-FLM | October 21, 1982 |
| K813216 | beckman instruments | SECURE FDI TEST KIT | December 17, 1981 |
| K811588 | helena laboratories | HELENA FETAL-TEK 200 METHOD | June 25, 1981 |
| K790798 | helena laboratories | FETAL MATURITY TEST PROCEDURE | June 5, 1979 |