The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Vironostika(tm) Anti-cmv Igm Microelisa System.
| Device ID | K890610 |
| 510k Number | K890610 |
| Device Name: | VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Toni M Stifano |
| Correspondent | Toni M Stifano ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-07 |
| Decision Date | 1989-06-23 |