The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Coag-a-mate - Ra4.
| Device ID | K900895 |
| 510k Number | K900895 |
| Device Name: | COAG-A-MATE - RA4 |
| Classification | System, Fibrinogen Determination |
| 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 | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-04-16 |