The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Platelin(r) Excel L.
| Device ID | K881999 |
| 510k Number | K881999 |
| Device Name: | PLATELIN(R) EXCEL L |
| Classification | Reagent & Control, Partial Thromboplastin Time |
| 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 | GIT |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-12 |
| Decision Date | 1988-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521420326 | K881999 | 000 |
| 15391521420319 | K881999 | 000 |