The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Simplastin Excel S.
| Device ID | K882214 |
| 510k Number | K882214 |
| Device Name: | SIMPLASTIN EXCEL S |
| Classification | Test, Time, Prothrombin |
| Applicant | ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Contact | Toni M Stifano |
| Correspondent | Toni M Stifano ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-26 |
| Decision Date | 1988-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391521420268 | K882214 | 000 |
| 05391521420251 | K882214 | 000 |