LGO · Class I · 21 CFR 864.7675

FDA Product Code LGO: Test, Leukocyte Typing

Leading manufacturers include Hyland Therapeutic Div., Travenol Laboratories, Calbiochem-Behring Corp. and Kallestad Diag, A Div. of Erbamont, Inc..

5
Total
5
Cleared
175d
Avg days
1977
Since

FDA 510(k) Cleared Test, Leukocyte Typing Devices (Product Code LGO)

5 devices
1–5 of 5
Cleared Mar 23, 1990
PLATELIA TOXO IGG KIT
K894947
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 232d
Cleared Aug 03, 1979
HLA CONTROL SERA
K791118
Calbiochem-Behring Corp.
Hematology · 49d
Cleared Apr 06, 1977
LYMPHOCYTE TYPING, NEGATIVE CONTROL
K761008
Hyland Therapeutic Div., Travenol Laboratories
Hematology · 155d
Cleared Apr 06, 1977
LYMPHOCYTE TYPING, POSITIVE CONTROL
K761009
Hyland Therapeutic Div., Travenol Laboratories
Hematology · 155d

About Product Code LGO - Regulatory Context