The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Nuclisens Cmv Pp67.
| Device ID | K983762 |
| 510k Number | K983762 |
| Device Name: | NUCLISENS CMV PP67 |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ron Sanyal |
| Correspondent | Ron Sanyal ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-26 |
| Decision Date | 1999-09-15 |
| Summary: | summary |