KIR · Class I · 21 CFR 864.2280

FDA Product Code KIR: Cells, Animal And Human, Cultured

Leading manufacturers include Proteins Intl., Inc., Diagnostic Hybrids, Inc. and Bartels Immunodiagnostic Supplies, Inc..

170
Total
170
Cleared
75d
Avg days
1978
Since
170 devices
73–96 of 170
Cleared Jun 22, 1984
PRIMARY RABBITT KIDNEY CELL CULTURE
K842000
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Mar 22, 1984
HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN
K834117
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
MCCOY CELLS
K834119
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
LLC-MK2-RHESUS MONKEY KIDNEY CELLS
K834120
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
WI-38 HUMAN LUNG CELLS
K834123
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
VERO CELLS
K834124
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
MRC-5 CELLS
K834126
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Sep 29, 1983
ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO
K832947
Ortho Diagnostic Systems, Inc.
Pathology · 29d