The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Coag-a-mate Xc/xc Plus Version D.00 Software.
| Device ID | K885076 |
| 510k Number | K885076 |
| Device Name: | COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Toni M Stifano |
| Correspondent | Toni M Stifano ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-08 |
| Decision Date | 1988-12-30 |