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
97–120 of 170
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 May 13, 1987
BUFFALO GREEN MONKEY KIDNEY CELLS
K871613
Viromed Laboratories, Inc.
Pathology · 19d
Cleared Dec 31, 1986
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
K864776
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 23d
Cleared Jul 10, 1986
HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)
K862555
Viromed Laboratories, Inc.
Pathology · 7d
Cleared May 13, 1986
ULTRACLONE 01-2300 CELL LINE
K861585
Earl-Clay Laboratories, Inc.
Pathology · 14d
Cleared May 05, 1986
ULTRACLONE 01-700 CELL LINE
K861569
Earl-Clay Laboratories, Inc.
Pathology · 7d
Cleared Apr 18, 1986
HUMAN LUNG CARCINOMA CELLS (A549)
K861373
Viromed Laboratories, Inc.
Pathology · 7d
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 Aug 12, 1985
ULTRACLONE ECL-01-2200 CELL LINE
K853203
Earl-Clay Laboratories, Inc.
Pathology · 13d
Cleared Jul 12, 1985
MDCK
K852394
Viromed Laboratories, Inc.
Pathology · 36d
Cleared Jul 12, 1985
MINK LUNG
K852395
Viromed Laboratories, Inc.
Pathology · 36d
Cleared Jul 12, 1985
HEK
K852396
Viromed Laboratories, Inc.
Pathology · 36d
Cleared May 10, 1985
ULTRACLONE ECL-01-800 CELL LINE
K851545
Earl-Clay Laboratories, Inc.
Pathology · 24d
Cleared Jan 08, 1985
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366
Difco Laboratories, Inc.
Microbiology · 347d
Cleared Oct 31, 1984
ULTRAXLONE ECL-01-1000 CELL LINE
K843577
Earl-Clay Laboratories, Inc.
Hematology · 50d
Cleared Oct 31, 1984
ULTRACLONE ECL-01-2100 CELL LINE
K843578
Earl-Clay Laboratories, Inc.
Hematology · 50d