Genzyme Diagnostics
Genzyme Diagnostics appears in FDA public data with 0 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 12, 2005.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K043385 | OSOM HCG COMBO TEST | April 12, 2005 |
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY | January 11, 1999 |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | February 25, 1997 |
| K964155 | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST | November 25, 1996 |
| K964156 | CONTRAST STRIP HCG | November 25, 1996 |