The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Washer 500 Microelisa System.
| Device ID | K884695 |
| 510k Number | K884695 |
| Device Name: | WASHER 500 MICROELISA SYSTEM |
| Classification | Device, Microtiter Diluting/dispensing |
| 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 | JTC |
| CFR Regulation Number | 866.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-09 |
| Decision Date | 1988-12-13 |