JHG · Class II · 21 CFR 862.1455

FDA Product Code JHG: Chromatographic Separation, Lecithin/sphingomyelin Ratio

Leading manufacturers include Helena Laboratories, Abbott Laboratories and Beckman Instruments, Inc..

7
Total
7
Cleared
83d
Avg days
1979
Since

FDA 510(k) Cleared Chromatographic Separation, Lecithin/sphingomyelin Ratio Devices (Product Code JHG)

7 devices
1–7 of 7
Cleared Jul 20, 1987
TDXR FETAL LUNG MATURITY
K871593
Abbott Laboratories
Chemistry · 87d
Cleared Dec 17, 1981
SECURE FDI TEST KIT
K813216
Beckman Instruments, Inc.
Chemistry · 38d
Cleared Jun 25, 1981
HELENA FETAL-TEK 200 METHOD
K811588
Helena Laboratories
Chemistry · 17d
Cleared Jun 05, 1979
FETAL MATURITY TEST PROCEDURE
K790798
Helena Laboratories
Chemistry · 49d

About Product Code JHG - Regulatory Context