The following data is part of a premarket notification filed by Genzyme Diagnostics with the FDA for Genzyme Diagnostics Contrast Mono.
| Device ID | K963425 |
| 510k Number | K963425 |
| Device Name: | GENZYME DIAGNOSTICS CONTRAST MONO |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | GENZYME DIAGNOSTICS 1531 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Delia R Bethell, Ph.d. |
| Correspondent | Delia R Bethell, Ph.d. GENZYME DIAGNOSTICS 1531 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1997-02-25 |
| Summary: | summary |