The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Simplate Pediatric.
| Device ID | K911745 |
| 510k Number | K911745 |
| Device Name: | SIMPLATE PEDIATRIC |
| Classification | Device, Bleeding Time |
| 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 | JCA |
| CFR Regulation Number | 864.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-18 |
| Decision Date | 1991-08-09 |