Atlas FDA

KIR

170 FDA 510(k) clearances · Product code

56 daysmedian time to decision
130 days90th percentile
170clearances measured

FDA profile

Official device name
Cells, Animal And Human, Cultured
Device class
Class I (low risk)
Regulation
21 CFR 864.2280
Medical specialty
Hematology
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RecordFirmDate
FRESH CELLS WI-38 (K973212)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS MV1LU (K973211)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS NCI H292 (K973210)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS VERO (K973209)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS HFF (K973214)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS LLC-MK2 (K973213)Diagnostic Hybrids, Inc.1997-09-25
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (K971508)Bio-Whittaker, Inc., A Cambrex Co.1997-09-17
FRESHCELLS (K972414)Diagnostic Hybrids, Inc.1997-08-29
MINK LUNG CELL CULTURE (K965047)Neogenex1997-02-04
FRESHFROZENCELLS (K962311)Diagnostic Hybrids, Inc.1996-08-29
FRESHFROZEN CELLS, HEP-2 (K962782)Diagnostic Hybrids, Inc.1996-08-29
FRESHCELLS, HEP-2 (K962780)Diagnostic Hybrids, Inc.1996-08-29
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (K962306)Diagnostic Hybrids, Inc.1996-08-29
MCCOY CELL CULTURES (K955608)Vai Diagnostics, Inc.1996-07-08
H292 CELL CULTURE (K960909)Neogenex1996-05-30
NCI-H292 CELL CULTURE (K951461)Viromed Laboratories, Inc.1996-05-22
LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE (K951440)Viromed Laboratories, Inc.1996-05-22
A549 CELL CULTURE (K955921)Viratest Intl., Inc.1996-02-16
MRC-5 CELL CULTURE VIAL (K952727)Viratest Intl., Inc.1995-11-20
H292 (K942820)Bartels, Inc.1995-05-05
HUMAN NEWBORN FORESKIN CELL CULTURE (K943887)Neogenex1994-11-28
RD CULTURE CELL (K943891)Neogenex1994-11-28
PRIMARY RABBIT KIDNEY CELL CULTURE (K943885)Neogenex1994-11-28
VERO CELL CULTURE (K943889)Neogenex1994-11-28
PRIMARY MONKEY KIDNEY CELL CULTURE (K943884)Neogenex1994-11-28
WI38 CELL CULTURE (K943890)Neogenex1994-11-28
MDCK CELL CULTURE (K943888)Neogenex1994-11-28
BGM CELL CULTURE (K943886)Neogenex1994-11-28
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE (K936271)Diagnostic Hybrids, Inc.1994-08-26
FRESH FROZEN CELLS (K940502)Diagnostic Hybrids, Inc.1994-06-16
HEP-2 CULTURE CELL (K933927)Neogenex1994-03-31
A549 CULTURE CELL (K933923)Neogenex1994-03-29
MCCOY CULTURE CELL (K933924)Neogenex1994-03-29
MRC-5 CULTURE CELL (K933925)Neogenex1994-03-29
LLCMK2 CULTURE CELLS (K933926)Neogenex1994-03-29
RHESUS MONKEY KIDNEY CELLS (LLC-MK2) (K936172)Advanced Clinical Diagnostics1994-02-03
RHESUS MONKEY KIDNEY CELLS (K936169)Advanced Clinical Diagnostics1994-02-03
TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY (K936171)Advanced Clinical Diagnostics1994-02-03
HELA-229/HELA CELLS (K934973)Advanced Clinical Diagnostics1994-01-28
RABBIT KIDNEY CELLS - R.K.C. (K934934)Advanced Clinical Diagnostics1994-01-28
PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS (K935766)Advanced Clinical Diagnostics1994-01-24
RHABDOMYOSARCOMA CELLS (K935337)Advanced Clinical Diagnostics1994-01-03
HELA HELA EPITHELOID CARCINOMA (K935339)Advanced Clinical Diagnostics1994-01-03
HUMAN LUNG DIPLOID CELLS-MRC-5 (K934244)Advanced Clinical Diagnostics1994-01-03
HUMAN FORESKIN FIBROBLAST CELLS-H.F.F. (K934245)Advanced Clinical Diagnostics1994-01-03
KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO (K934240)Advanced Clinical Diagnostics1994-01-03
LUNG DIPLOID HUMAN CELLS-WI-38 (K934246)Advanced Clinical Diagnostics1994-01-03
LUNG CACINOMA, HUMAN CELLS (K935338)Advanced Clinical Diagnostics1994-01-03
BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K. (K934242)Advanced Clinical Diagnostics1994-01-03
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1 (K934239)Advanced Clinical Diagnostics1994-01-03
HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 (K934243)Advanced Clinical Diagnostics1994-01-03
MCCOY CULTURE CELLS-MCCOY (K934241)Advanced Clinical Diagnostics1994-01-03
CYNOMOLOGUS MONKEY KIDNEY CELLS (K935336)Advanced Clinical Diagnostics1994-01-03
16 X 125 MM TEST TUBE, CATALOG #01-111 (K930392)Proteins Intl., Inc.1993-03-24
16 X 125 MM TEST TUBE, CATALOG #01-441 (K930398)Proteins Intl., Inc.1993-03-24
25 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-211 (K930394)Proteins Intl., Inc.1993-03-24
25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291 (K930390)Proteins Intl., Inc.1993-03-24
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261 (K930391)Proteins Intl., Inc.1993-03-24
16 X 125 MM TEST TUBE, CATALOG (K930397)Proteins Intl., Inc.1993-03-24
ONE DRAM SHELL VIAL, CATALOG #02-261 (K930393)Proteins Intl., Inc.1993-03-24
16 X 125 MM TEST TUBE, CATALOG #01-291 (K930396)Proteins Intl., Inc.1993-03-24
ONE DRAM SHELL VIAL, CATALOG #02-461 (K930395)Proteins Intl., Inc.1993-03-24
25CM, 75CM, 150CM, FLASK, CATALOG #03-311 (K930369)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-441 (K930381)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-401 (K930387)Proteins Intl., Inc.1993-03-23
ONE DRAMSHELL VIAL, CATALOG #02-421 (K930382)Proteins Intl., Inc.1993-03-23
25CM2, 75CM2, 150CM2 FLASK, CATALOG #03-241 (K930365)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-401 (K930384)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441 (K930378)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-111 (K930373)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-421 (K930385)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-241 (K930388)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-281 (K930379)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG # 02-241 (K930364)Proteins Intl., Inc.1993-03-23
CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS (K930325)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIALS, CATALOG #02-311 (K930370)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2, FLASK, CATALOG #03-111 (K930374)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-461 (K930377)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-291 (K930389)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-321 (K930371)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-211 (K930376)Proteins Intl., Inc.1993-03-23
16 X 25 MM TEST TUBE, CATALOG #01-461 (K930366)Proteins Intl., Inc.1993-03-23
25CM2. 75CM2, 150 CM, FLASK, CATALOG #03-321 (K930367)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-311 (K930372)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-261 (K930380)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-401 (K930386)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-211 (K930375)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-321 (K930368)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-421 (K930383)Proteins Intl., Inc.1993-03-23
CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301 (K924613)Proteins Intl., Inc.1992-12-07
CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201 (K924624)Proteins Intl., Inc.1992-12-07
CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-251 (K924618)Proteins Intl., Inc.1992-12-07
CYTOQUANT A-549 CELLS, CATALOG #02-201 (K924622)Proteins Intl., Inc.1992-12-07
CYTOQUANT HEP-2 CELLS, CATALOG #02-251 (K924616)Proteins Intl., Inc.1992-12-07
CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101 (K924619)Proteins Intl., Inc.1992-12-07
CYTOQUANT HLNFS CELLS, CATLOG #03-151 (K924625)Proteins Intl., Inc.1992-12-07
CYTOQUANT MRC-5 CELLS, CATALOG #03-101 (K924620)Proteins Intl., Inc.1992-12-07
CYTOQUANT HEP-2 CELLS 16 X 125 MM TUBE, #01-251 (K924617)Proteins Intl., Inc.1992-12-07
CYTOQUANT H292 CELLS 25CM2/75CM2/175CM2 FLASK (K924615)Proteins Intl., Inc.1992-12-07
CYTOQUANT MRC-5 CELLS, CATALOG #02-101 (K924621)Proteins Intl., Inc.1992-12-07
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