KIR · Class I · 21 CFR 864.2280

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

Leading manufacturers include Proteins Intl., Inc., Viromed Laboratories, Inc. and Advanced Clinical Diagnostics.

170
Total
170
Cleared
75d
Avg days
1978
Since
170 devices
145–168 of 170
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
Cleared Jul 06, 1983
MRC-5 CELLS
K831679
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
VERO CELLS
K831680
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
HEP-2 CELLS
K831681
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
MCCOY CELLS
K831682
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
SF CELLS
K831683
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
CYNOMOLGUS MONKEY KIDNEY CELLS SV5
K831684
Viromed Laboratories, Inc.
Pathology · 43d