The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Mda Protein Assay.
| Device ID | K925617 |
| 510k Number | K925617 |
| Device Name: | MDA PROTEIN ASSAY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-06 |
| Decision Date | 1994-01-27 |