The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Coag-a-mate(r) Xm.
| Device ID | K881281 |
| 510k Number | K881281 |
| Device Name: | COAG-A-MATE(R) XM |
| Classification | Instrument, Coagulation, Automated |
| Applicant | ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Contact | Toni M Stifano |
| Correspondent | Toni M Stifano ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-25 |
| Decision Date | 1988-05-18 |