The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Simplastin Excel.
| Device ID | K864283 |
| 510k Number | K864283 |
| Device Name: | SIMPLASTIN EXCEL |
| Classification | Test, Time, Prothrombin |
| Applicant | ORGANON TEKNIKA CORP. 5516 NICHOLSON LN. Kensington, TX 20895 |
| Contact | Sheldon Mazursky |
| Correspondent | Sheldon Mazursky ORGANON TEKNIKA CORP. 5516 NICHOLSON LN. Kensington, TX 20895 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-30 |
| Decision Date | 1986-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391521420282 | K864283 | 000 |