Medical Device Manufacturer · US , Toledo , OH

Advanced Clinical Diagnostics - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1988

Recent clearances: RHESUS MONKEY KIDNEY CELLS, TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY, RHESUS MONKEY KIDNEY CELLS (LLC-MK2)

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Advanced Clinical Diagnostics Pathology ✕

18 devices

1-12 of 18

Cleared Feb 03, 1994

RHESUS MONKEY KIDNEY CELLS

Pathology · 42d

Cleared Feb 03, 1994

TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY

Pathology · 42d

Cleared Feb 03, 1994

RHESUS MONKEY KIDNEY CELLS (LLC-MK2)

Pathology · 42d

Cleared Jan 28, 1994

RABBIT KIDNEY CELLS - R.K.C.

Pathology · 155d

Cleared Jan 28, 1994

HELA-229/HELA CELLS

Pathology · 102d

Cleared Jan 24, 1994

PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS

Pathology · 80d

Cleared Jan 03, 1994

KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1

Pathology · 130d

Cleared Jan 03, 1994

KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO

Pathology · 130d

Cleared Jan 03, 1994

MCCOY CULTURE CELLS-MCCOY

Pathology · 130d

Cleared Jan 03, 1994

BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.

Pathology · 130d

Cleared Jan 03, 1994

HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2

Pathology · 130d

Cleared Jan 03, 1994

HUMAN LUNG DIPLOID CELLS-MRC-5

Pathology · 130d