The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Microplate Processor 3000.
| Device ID | K945135 |
| 510k Number | K945135 |
| Device Name: | MICROPLATE PROCESSOR 3000 |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-20 |
| Decision Date | 1995-03-03 |