Medical Device Manufacturer · US , Toledo , OH

Advanced Clinical Diagnostics - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1988
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Advanced Clinical Diagnostics Pathology
18 devices
1-18 of 18
Cleared Feb 03, 1994
RHESUS MONKEY KIDNEY CELLS
K936169 · KIR
Pathology · 42d
Cleared Feb 03, 1994
TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY
K936171 · KIR
Pathology · 42d
Cleared Feb 03, 1994
RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
K936172 · KIR
Pathology · 42d
Cleared Jan 28, 1994
RABBIT KIDNEY CELLS - R.K.C.
K934934 · KIR
Pathology · 155d
Cleared Jan 28, 1994
HELA-229/HELA CELLS
K934973 · KIR
Pathology · 102d
Cleared Jan 24, 1994
PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
K935766 · KIR
Pathology · 80d
Cleared Jan 03, 1994
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1
K934239 · KIR
Pathology · 130d
Cleared Jan 03, 1994
KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO
K934240 · KIR
Pathology · 130d
Cleared Jan 03, 1994
MCCOY CULTURE CELLS-MCCOY
K934241 · KIR
Pathology · 130d
Cleared Jan 03, 1994
BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.
K934242 · KIR
Pathology · 130d
Cleared Jan 03, 1994
HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2
K934243 · KIR
Pathology · 130d
Cleared Jan 03, 1994
HUMAN LUNG DIPLOID CELLS-MRC-5
K934244 · KIR
Pathology · 130d
Cleared Jan 03, 1994
HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.
K934245 · KIR
Pathology · 130d
Cleared Jan 03, 1994
LUNG DIPLOID HUMAN CELLS-WI-38
K934246 · KIR
Pathology · 130d
Cleared Jan 03, 1994
CYNOMOLOGUS MONKEY KIDNEY CELLS
K935336 · KIR
Pathology · 59d
Cleared Jan 03, 1994
RHABDOMYOSARCOMA CELLS
K935337 · KIR
Pathology · 59d
Cleared Jan 03, 1994
LUNG CACINOMA, HUMAN CELLS
K935338 · KIR
Pathology · 59d
Cleared Jan 03, 1994
HELA HELA EPITHELOID CARCINOMA
K935339 · KIR
Pathology · 59d
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