The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Coag-a-mate(r) Xc.
| Device ID | K870960 |
| 510k Number | K870960 |
| Device Name: | COAG-A-MATE(R) XC |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Contact | Bruce Weber |
| Correspondent | Bruce Weber ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-10 |
| Decision Date | 1987-03-17 |