The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Mda Simplastin Ls.
| Device ID | K952608 |
| 510k Number | K952608 |
| Device Name: | MDA SIMPLASTIN LS |
| Classification | Test, Time, Prothrombin |
| 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 | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-07 |
| Decision Date | 1995-10-06 |