Medical Device Manufacturer · US , Washington , DC

Bioclone Australia Pty , Ltd. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1990

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bioclone Australia Pty , Ltd. Chemistry ✕

8 devices

1-8 of 8

Cleared Oct 03, 1994

ELEGANCE NEONATAL TSH ELISA

Chemistry · 348d

Cleared Jul 10, 1992

ELEGANCE FT4 ELISA

Chemistry · 56d

Cleared Feb 26, 1991

BIOCLONE'S ELEGANCE HCG ELISA KIT

Chemistry · 27d

Cleared Dec 18, 1990

ELEGANCE TSH ELISA

Chemistry · 35d

Cleared Dec 06, 1990

ELEGANCE GH ELISA

Chemistry · 23d

Cleared Nov 06, 1990

BIOCLONES ELEGANCE LH ELISA KIT

Chemistry · 42d

Cleared Nov 05, 1990

ELEGANCE PROLACTIN ELISA

Chemistry · 34d

Cleared Oct 26, 1990

BIOCLONES ELEGANCE FSH ELISA KIT

Chemistry · 31d