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
25–48 of 170
Cleared Nov 28, 1994
WI38 CELL CULTURE
K943890
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
RD CULTURE CELL
K943891
Neogenex
Pathology · 111d
Cleared Aug 26, 1994
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
K936271
Diagnostic Hybrids, Inc.
Pathology · 239d
Cleared Jun 16, 1994
FRESH FROZEN CELLS
K940502
Diagnostic Hybrids, Inc.
Pathology · 134d
Cleared Mar 31, 1994
HEP-2 CULTURE CELL
K933927
Neogenex
Pathology · 233d
Cleared Mar 29, 1994
A549 CULTURE CELL
K933923
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
MCCOY CULTURE CELL
K933924
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
MRC-5 CULTURE CELL
K933925
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
LLCMK2 CULTURE CELLS
K933926
Neogenex
Pathology · 231d
Cleared Feb 03, 1994
RHESUS MONKEY KIDNEY CELLS
K936169
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Feb 03, 1994
TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY
K936171
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Feb 03, 1994
RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
K936172
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Jan 28, 1994
RABBIT KIDNEY CELLS - R.K.C.
K934934
Advanced Clinical Diagnostics
Pathology · 155d
Cleared Jan 28, 1994
HELA-229/HELA CELLS
K934973
Advanced Clinical Diagnostics
Pathology · 102d
Cleared Jan 24, 1994
PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
K935766
Advanced Clinical Diagnostics
Pathology · 80d
Cleared Jan 03, 1994
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1
K934239
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO
K934240
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
MCCOY CULTURE CELLS-MCCOY
K934241
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.
K934242
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2
K934243
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN LUNG DIPLOID CELLS-MRC-5
K934244
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.
K934245
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
LUNG DIPLOID HUMAN CELLS-WI-38
K934246
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
CYNOMOLOGUS MONKEY KIDNEY CELLS
K935336
Advanced Clinical Diagnostics
Pathology · 59d