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Cells, Animal And Human, Cultured

FDA product code KIR · 170 cleared devices

Class 1 Hematology

Regulation: 21 CFR 864.2280
Review panel: PA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-08-14 – 1997-09-25

KIR 1992-12-07

CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS

Applicant Proteins Intl., Inc.

K number K924614

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KIR 1992-12-07

CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301

Applicant Proteins Intl., Inc.

K number K924613

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KIR 1992-12-07

CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301

Applicant Proteins Intl., Inc.

K number K924612

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KIR 1992-12-07

CYTOQUANT HNFS CELLS

Applicant Proteins Intl., Inc.

K number K924595

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KIR 1990-09-24

BARTELS EXTRACELLULAR MATRIX

Applicant Baxter Healthcare Corp

K number K902726

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KIR 1990-02-01

MADIN-DARBY CANINE KIDNEY CULTURE CELLS

Applicant Baxter Healthcare Corp

K number K896846

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KIR 1987-05-13

BUFFALO GREEN MONKEY KIDNEY CELLS

Applicant Viromed Laboratories, Inc.

K number K871613

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KIR 1987-03-31

RABBIT KIDNEY CULTURE CELLS (FIRST PASS)

Applicant Microscan Div. Baxter Healthcare Corp.

K number K871033

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KIR 1986-12-31

A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K864776

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KIR 1986-07-10

HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)

Applicant Viromed Laboratories, Inc.

K number K862555

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KIR 1986-05-13

ULTRACLONE 01-2300 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K861585

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KIR 1986-05-05

ULTRACLONE 01-700 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K861569

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KIR 1986-04-18

HUMAN LUNG CARCINOMA CELLS (A549)

Applicant Viromed Laboratories, Inc.

K number K861373

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KIR 1986-02-05

CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS

Applicant Difco Laboratories, Inc.

K number K860293

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KIR 1986-02-05

CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000

Applicant Difco Laboratories, Inc.

K number K860292

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KIR 1985-08-12

ULTRACLONE ECL-01-2200 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K853203

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KIR 1985-07-12

HEK

Applicant Viromed Laboratories, Inc.

K number K852396

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KIR 1985-07-12

MINK LUNG

Applicant Viromed Laboratories, Inc.

K number K852395

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KIR 1985-07-12

MDCK

Applicant Viromed Laboratories, Inc.

K number K852394

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KIR 1985-06-04

HEP-2 GENCELLS

Applicant Genus Diagnostics

K number K852206

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KIR 1985-06-04

RMK GENCELLS CULTURE SYSTEM

Applicant Genus Diagnostics

K number K852205

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KIR 1985-06-04

MCCOY GENCELLS

Applicant Genus Diagnostics

K number K852204

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KIR 1985-05-20

HEK GENCELLS

Applicant Genus Diagnostics

K number K851928

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KIR 1985-05-20

VERO GENCELLS

Applicant Genus Diagnostics

K number K851927

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KIR 1985-05-10

RK GENCELLS

Applicant Genus Diagnostics

K number K851563

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KIR 1985-05-10

MRC-5 GENCELLS

Applicant Genus Diagnostics

K number K851562

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KIR 1985-05-10

WI-38 GENCELLS

Applicant Genus Diagnostics

K number K851561

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KIR 1985-05-10

ULTRACLONE ECL-01-800 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K851545

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KIR 1985-01-08

CELL-MATICS HERPES SIMPLEX VIRUS DETECT

Applicant Difco Laboratories, Inc.

K number K840366

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KIR 1984-10-31

ULTRACLONE ECL-01-1100

Applicant Earl-Clay Laboratories, Inc.

K number K843579

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KIR 1984-10-31

ULTRACLONE ECL-01-2100 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K843578

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KIR 1984-10-31

ULTRAXLONE ECL-01-1000 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K843577

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KIR 1984-09-06

AFRICAN GREEN SV 5/SV 40

Applicant Viromed Laboratories, Inc.

K number K843252

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KIR 1984-09-06

RD CELLS

Applicant Viromed Laboratories, Inc.

K number K843251

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KIR 1984-09-06

BHK-21

Applicant Viromed Laboratories, Inc.

K number K843250

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KIR 1984-07-27

HEK

Applicant Viromed Laboratories, Inc.

K number K842584

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KIR 1984-07-27

SIRC

Applicant Viromed Laboratories, Inc.

K number K842583

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KIR 1984-06-27

IMR-90-DIPLOID-HUMAN FETAL LUNG CELL

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K841998

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KIR 1984-06-22

PRIMARY RABBITT KIDNEY CELL CULTURE

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K842000

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KIR 1984-06-22

BGM CELL CULTURE AFRICAN GREEN MONKEY

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K841999

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KIR 1984-06-07

WI-38

Applicant Viromed Laboratories, Inc.

K number K841806

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KIR 1984-05-11

ULTRACLONE ECL-01-200 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841346

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KIR 1984-05-11

ULTRACLONE ECL-01-500 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841345

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KIR 1984-05-11

ULTRACLONE ECL-01-300 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841344

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KIR 1984-05-11

ULTRACLONE ECL-01-100 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841343

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KIR 1984-05-11

ULTRACLONE ECL-01-400 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841342

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KIR 1984-05-11

ULTRACLONE ECL-01-1000 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841341

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KIR 1984-05-11

ULTRACLONE ECL-01-900 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841340

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KIR 1984-05-11

ULTRA CLONE ECL-01-700 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841339

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KIR 1984-05-11

ULTRACLONE ECL-01-600 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841338

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KIR 1984-05-11

ULTRACLONE ECL-01-800 CELL LINE

Applicant Earl-Clay Laboratories, Inc.

K number K841337

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KIR 1984-05-07

RABBIT KIDNEY CELLS

Applicant Viromed Laboratories, Inc.

K number K841666

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KIR 1984-05-07

RHESUS SV5/SV40

Applicant Viromed Laboratories, Inc.

K number K841665

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KIR 1984-03-22

MRC-5 CELLS

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K834126

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KIR 1984-03-22

VERO CELLS

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K834124

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KIR 1984-03-22

WI-38 HUMAN LUNG CELLS

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K834123

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KIR 1984-03-22

LLC-MK2-RHESUS MONKEY KIDNEY CELLS

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K834120

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KIR 1984-03-22

MCCOY CELLS

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K834119

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KIR 1984-03-22

HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN

Applicant Bartels Immunodiagnostic Supplies, Inc.

K number K834117

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KIR 1983-11-03

HEP-2 CELLS

Applicant Biocon, Inc.

K number K833360

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KIR 1983-11-03

WI-38 CELLS

Applicant Biocon, Inc.

K number K833359

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KIR 1983-11-03

MRC-5 CELLS

Applicant Biocon, Inc.

K number K833358

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KIR 1983-09-29

ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO

Applicant Ortho Diagnostic Systems, Inc.

K number K832947

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KIR 1983-07-06

CYNOMOLGUS MONKEY KIDNEY CELLS SV5

Applicant Viromed Laboratories, Inc.

K number K831684

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KIR 1983-07-06

SF CELLS

Applicant Viromed Laboratories, Inc.

K number K831683

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KIR 1983-07-06

MCCOY CELLS

Applicant Viromed Laboratories, Inc.

K number K831682

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KIR 1983-07-06

HEP-2 CELLS

Applicant Viromed Laboratories, Inc.

K number K831681

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KIR 1983-07-06

VERO CELLS

Applicant Viromed Laboratories, Inc.

K number K831680

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KIR 1983-07-06

MRC-5 CELLS

Applicant Viromed Laboratories, Inc.

K number K831679

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KIR 1978-08-14

CELL CULTURE LINES

Applicant Bioassay Systems Research Corp.

K number K780869

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