Wellcome Diagnostics - FDA 510(k) Cleared Devices
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wellcome Diagnostics Microbiology ✕
12 devices
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
May 22, 1985
STAPHAUREX ZL30
Microbiology
19d
Cleared
May 02, 1984
WELLCOGEN S. PNEUMONIAE
Microbiology
29d