The following data is part of a premarket notification filed by Genzyme Diagnostics with the FDA for Giardia/cryptosporidium Combo Rapid Assay.
| Device ID | K983399 |
| 510k Number | K983399 |
| Device Name: | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY |
| Classification | Giardia Spp. |
| Applicant | GENZYME DIAGNOSTICS ONE KENDALL SQUARE Cambridge, MA 02139 -1562 |
| Contact | Barbara Pizza |
| Correspondent | Barbara Pizza GENZYME DIAGNOSTICS ONE KENDALL SQUARE Cambridge, MA 02139 -1562 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-28 |
| Decision Date | 1999-01-11 |
| Summary: | summary |