Bioclone Australia Pty , Ltd. is one of 26109 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bioclone Australia Pty , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ELEGANCE NEONATAL TSH ELISA, ELEGANCE FT4 ELISA, BIOCLONE'S ELEGANCE IGE ELISA KIT
10
Total
10
Cleared
0
Denied
Bioclone Australia Pty , Ltd. has 10 FDA 510(k) cleared chemistry devices. Based in Washington, US.
Historical record: 10 cleared submissions from 1990 to 1994.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Bioclone Australia Pty , Ltd.
10 devices
Cleared
Oct 03, 1994
ELEGANCE NEONATAL TSH ELISA
Chemistry
348d
Cleared
Jul 10, 1992
ELEGANCE FT4 ELISA
Chemistry
56d
Cleared
Jun 21, 1991
BIOCLONE'S ELEGANCE IGE ELISA KIT
Immunology
142d
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 29, 1990
ELEGANCE FERRITIN ELISA
Immunology
36d
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