Medical Device Manufacturer · AU , Pyrmont

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

4 submissions · 4 cleared · Since 1990

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Feb 16, 2000

GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05

Hematology · 135d

Cleared Dec 21, 1999

GRADILEIDEN V TEST

Hematology · 151d

Cleared Apr 06, 1993

LUCOR CONFIRMATORY REAGENT

Hematology · 334d

Cleared Dec 17, 1990

LUPO-TEST REAGENT

Hematology · 159d