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
121–144 of 170
Cleared Oct 31, 1984
ULTRACLONE ECL-01-1100
K843579
Earl-Clay Laboratories, Inc.
Hematology · 50d
Cleared Sep 06, 1984
BHK-21
K843250
Viromed Laboratories, Inc.
Pathology · 17d
Cleared Sep 06, 1984
RD CELLS
K843251
Viromed Laboratories, Inc.
Pathology · 17d
Cleared Sep 06, 1984
AFRICAN GREEN SV 5/SV 40
K843252
Viromed Laboratories, Inc.
Pathology · 17d
Cleared Jul 27, 1984
SIRC
K842583
Viromed Laboratories, Inc.
Pathology · 24d
Cleared Jul 27, 1984
HEK
K842584
Viromed Laboratories, Inc.
Pathology · 24d
Cleared Jun 27, 1984
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL
K841998
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 42d
Cleared Jun 22, 1984
BGM CELL CULTURE AFRICAN GREEN MONKEY
K841999
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Jun 22, 1984
PRIMARY RABBITT KIDNEY CELL CULTURE
K842000
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Jun 07, 1984
WI-38
K841806
Viromed Laboratories, Inc.
Pathology · 37d
Cleared May 11, 1984
ULTRACLONE ECL-01-800 CELL LINE
K841337
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-600 CELL LINE
K841338
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRA CLONE ECL-01-700 CELL LINE
K841339
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-900 CELL LINE
K841340
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-1000 CELL LINE
K841341
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-400 CELL LINE
K841342
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-100 CELL LINE
K841343
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-300 CELL LINE
K841344
Earl-Clay Laboratories, Inc.
Chemistry · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-500 CELL LINE
K841345
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 11, 1984
ULTRACLONE ECL-01-200 CELL LINE
K841346
Earl-Clay Laboratories, Inc.
Hematology · 39d
Cleared May 07, 1984
RHESUS SV5/SV40
K841665
Viromed Laboratories, Inc.
Pathology · 14d
Cleared May 07, 1984
RABBIT KIDNEY CELLS
K841666
Viromed Laboratories, Inc.
Pathology · 14d
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