LGL · Class II · 21 CFR 864.7500

FDA Product Code LGL: Assay, Bart's, Hemoglobin

Leading manufacturers include Isolab, Inc..

2
Total
2
Cleared
111d
Avg days
1981
Since

FDA 510(k) Cleared Assay, Bart's, Hemoglobin Devices (Product Code LGL)

2 devices
1–2 of 2
Cleared May 29, 1981
ALPHA-THAL SCREEN TM CONTROL
K810976
Isolab, Inc.
Chemistry · 49d
Cleared Jan 16, 1981
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
K801771
Isolab, Inc.
Hematology · 172d

About Product Code LGL - Regulatory Context