Company ยท US
Genzyme Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2005. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 2005 | K043385 | OSOM HCG COMBO TEST Genzyme Diagnostics | JHI |
| Jan 11, 1999 | K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY Genzyme Diagnostics | MHI |
| Feb 25, 1997 | K963425 | GENZYME DIAGNOSTICS CONTRAST MONO Genzyme Diagnostics | KTN |
| Nov 25, 1996 | K964156 | CONTRAST STRIP HCG Genzyme Diagnostics | JHI |
| Nov 25, 1996 | K964155 | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST Genzyme Diagnostics | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Genzyme Diagnostics Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits.
These are sold under two names as follows:
Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac G Terminated |
MHI | K983399 |