The following data is part of a premarket notification filed by Genzyme Diagnostics with the FDA for Contrast Hcg Urine/serum Test And Rapid Hcg Urine/serum Test.
| Device ID | K964155 |
| 510k Number | K964155 |
| Device Name: | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | GENZYME DIAGNOSTICS 1531 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Delia R Bethell |
| Correspondent | Delia R Bethell GENZYME DIAGNOSTICS 1531 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-16 |
| Decision Date | 1996-11-25 |
| Summary: | summary |