The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Fibrinostika(r) Fgdp Microelisa System.
| Device ID | K924892 |
| 510k Number | K924892 |
| Device Name: | FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM |
| Classification | Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ron Sanlyal |
| Correspondent | Ron Sanlyal ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | DAT |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-29 |
| Decision Date | 1994-04-21 |