JHG — Chromatographic Separation, Lecithin/Sphingomyelin Ratio Class II
FDA product code JHG covers "Chromatographic Separation, Lecithin/Sphingomyelin Ratio", a Class II medical device regulated under 21 CFR 862.1455. Submissions are reviewed by the Clinical Chemistry panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JHG
- Device Class
- Class II
- Regulation Number
- 862.1455
- Submission Type
- 510(k)
- 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 | Oct 18, 2006 |
| K871593 | Abbott Laboratories | TDXR FETAL LUNG MATURITY | Jul 20, 1987 |
| K834616 | Hana Biologics | AMNIO STAT-FLM AGGLUTINATION TEST | May 25, 1984 |
| K822150 | Hana Biologics | AMNISTAT-FLM | Oct 21, 1982 |
| K813216 | Beckman Instruments | SECURE FDI TEST KIT | Dec 17, 1981 |
| K811588 | Helena Laboratories | HELENA FETAL-TEK 200 METHOD | Jun 25, 1981 |
| K790798 | Helena Laboratories | FETAL MATURITY TEST PROCEDURE | Jun 5, 1979 |