Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Chromatographic Separation for Lecithin/Sphingomyelin Ratio is a clinical chemistry test system that uses chromatographic techniques to separate and quantify lecithin and sphingomyelin in amniotic fluid, providing the L/S ratio as a measure of fetal pulmonary maturity. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JHG, regulated under 21 CFR 862.1455, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JHG
- Device Class
- FDA class 2
- Regulation Number
- 862.1455
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K061549 | AMNIOSTAT-FLM-PG | Oct 18, 2006 | Substantially Equivalent | Irvine Scientific Sales Co., Inc. |
| K871593 | TDXR FETAL LUNG MATURITY | Jul 20, 1987 | Substantially Equivalent | Abbott Laboratories |
| K834616 | AMNIO STAT-FLM AGGLUTINATION TEST | May 25, 1984 | Substantially Equivalent | Hana Biologics, Inc. |
| K822150 | AMNISTAT-FLM | Oct 21, 1982 | Substantially Equivalent | Hana Biologics, Inc. |
| K813216 | SECURE FDI TEST KIT | Dec 17, 1981 | Substantially Equivalent | Beckman Instruments, Inc. |
| K811588 | HELENA FETAL-TEK 200 METHOD | Jun 25, 1981 | Substantially Equivalent | Helena Laboratories |
| K790798 | FETAL MATURITY TEST PROCEDURE | Jun 05, 1979 | Substantially Equivalent | Helena Laboratories |