Medical Device Manufacturer · GB , Bedford Mk41 Oqg

Unipath , Ltd. - FDA 510(k) Cleared Devices

73 submissions · 73 cleared · Since 1986

73

Total

73

Cleared

0

Denied

FDA 510(k) Regulatory Record - Unipath , Ltd. Hematology ✕

7 devices

1-7 of 7

Cleared Nov 22, 1991

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER

Hematology · 120d

Cleared Oct 04, 1990

CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY

Hematology · 50d

Cleared Sep 10, 1990

CELL-DYN CALIBRATOR

Hematology · 70d

Cleared Aug 22, 1990

CELL-DYN 3000 CONTROL

Hematology · 84d

Cleared Dec 20, 1988

TURBOX ANTITHROMBIN III

Hematology · 81d

Cleared Dec 20, 1988

TURBOX FIBRINOGEN

Hematology · 81d

Cleared Sep 23, 1987

Hematology · 30d