Genzyme Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Genzyme Diagnostics - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Genzyme Diagnostics has 5 FDA 510(k) cleared medical devices. Based in San Diegi, US.
Historical record: 5 cleared submissions from 1996 to 2005. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Genzyme Diagnostics Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Genzyme Diagnostics
5 devices
Cleared
Apr 12, 2005
OSOM HCG COMBO TEST
Chemistry
124d
Cleared
Jan 11, 1999
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
Microbiology
105d
Cleared
Feb 25, 1997
GENZYME DIAGNOSTICS CONTRAST MONO
Immunology
179d
Cleared
Nov 25, 1996
CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
Chemistry
40d
Cleared
Nov 25, 1996
CONTRAST STRIP HCG
Chemistry
40d