The following data is part of a premarket notification filed by Diatech, Inc. with the FDA for Heparin Coagulation Control Plasma 1-.
| Device ID | K841462 |
| 510k Number | K841462 |
| Device Name: | HEPARIN COAGULATION CONTROL PLASMA 1- |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | DIATECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-09 |
| Decision Date | 1984-06-01 |