JHGClass II
Chromatographic Separation, Lecithin/Sphingomyelin Ratio
21 CFR 862.1455 / Clinical Chemistry
JHG is the FDA product code for Chromatographic Separation, Lecithin/Sphingomyelin Ratio, a class II device type, regulated under 21 CFR 862.1455. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JHG
- Device name
- Chromatographic Separation, Lecithin/Sphingomyelin Ratio
- Regulation
- 21 CFR 862.1455
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code JHG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 2 |
| 1982 | 1 |
| 1984 | 1 |
| 1987 | 1 |
| 2006 | 1 |
Applicants with the most clearances
Product code JHG| Applicant | Clearances |
|---|---|
| Hana Biologics, Inc. | 2 |
| Helena Laboratories, Corp. | 2 |
| Abbott Medical | 1 |
| Beckman Instruments, Inc. | 1 |
| FUJIFILM Biosciences Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code JHG.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.