The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Platelin L.
| Device ID | K921396 |
| 510k Number | K921396 |
| Device Name: | PLATELIN L |
| Classification | Activated Partial Thromboplastin |
| 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 | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-23 |
| Decision Date | 1992-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391521420305 | K921396 | 000 |
| 05391521420299 | K921396 | 000 |