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
49–72 of 170
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-291
K930389
Proteins Intl., Inc.
Pathology · 56d
Cleared Dec 07, 1992
CYTOQUANT HNFS CELLS
K924595
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301
K924612
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301
K924613
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS
K924614
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT H292 CELLS 25CM2/75CM2/175CM2 FLASK
K924615
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT HEP-2 CELLS, CATALOG #02-251
K924616
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT HEP-2 CELLS 16 X 125 MM TUBE, #01-251
K924617
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-251
K924618
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101
K924619
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS, CATALOG #03-101
K924620
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS, CATALOG #02-101
K924621
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, CATALOG #02-201
K924622
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, CATALOG #03-201
K924623
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201
K924624
Proteins Intl., Inc.
Pathology · 87d
Cleared Dec 07, 1992
CYTOQUANT HLNFS CELLS, CATLOG #03-151
K924625
Proteins Intl., Inc.
Pathology · 87d
Cleared Sep 24, 1990
BARTELS EXTRACELLULAR MATRIX
K902726
Baxter Healthcare Corp
Pathology · 95d
Cleared Feb 01, 1990
MADIN-DARBY CANINE KIDNEY CULTURE CELLS
K896846
Baxter Healthcare Corp
Pathology · 58d
Cleared Dec 31, 1986
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
K864776
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 23d
Cleared Feb 05, 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000
K860292
Difco Laboratories, Inc.
Pathology · 8d
Cleared Feb 05, 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
K860293
Difco Laboratories, Inc.
Pathology · 8d
Cleared Jan 08, 1985
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366
Difco Laboratories, Inc.
Microbiology · 347d
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