The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Genzyme Contrast Ii Hcg Urine/serum Test.
| Device ID | K023544 |
| 510k Number | K023544 |
| Device Name: | GENZYME CONTRAST II HCG URINE/SERUM TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | E.v. Goorchenko |
| Correspondent | E.v. Goorchenko GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-22 |
| Decision Date | 2003-01-16 |
| Summary: | summary |