Wellcome Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Wellcome Diagnostics - FDA 510(k) Cleared Devices
28
Total
28
Cleared
0
Denied
Wellcome Diagnostics has 28 FDA 510(k) cleared medical devices. Based in Walker, US.
Historical record: 28 cleared submissions from 1983 to 1992. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Wellcome Diagnostics Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Wellcome Diagnostics
28 devices
Cleared
Jan 31, 1992
D-DIMER WELLCOTEST (HA10)
Hematology
74d
Cleared
Mar 29, 1991
STREPTEX ACID EXTRACTION KIT
Microbiology
31d
Cleared
Jan 11, 1990
WELLCOLEX COLOUR SHIGELLA TEST ZC51
Microbiology
127d
Cleared
Feb 16, 1989
WELLCOLEX COLOUR SALMONELLA TEST ZL 50
Microbiology
34d
Cleared
Aug 03, 1988
WELLCOZYME HSV WZO2
Microbiology
218d
Cleared
Jan 21, 1987
WELLCOZYME ROTAVIRUS WZ01
Microbiology
267d
Cleared
Jan 13, 1987
REVEAL COLOUR STREP A ZL16
Microbiology
78d
Cleared
Oct 29, 1986
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
Microbiology
183d
Cleared
Feb 04, 1986
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
Microbiology
61d
Cleared
Feb 04, 1986
WELLCOGEN BACTERIAL ANTIGEN KIT
Microbiology
61d
Cleared
Jun 10, 1985
WILLCOGEN MENINGITIDIS KIT ZL25
Microbiology
48d
Cleared
Jun 04, 1985
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
Immunology
179d