The following data is part of a premarket notification filed by General Diagnostics with the FDA for Sulfate, Fibriquik Protamine.
| Device ID | K781814 |
| 510k Number | K781814 |
| Device Name: | SULFATE, FIBRIQUIK PROTAMINE |
| Classification | Fibrin Monomer Paracoagulation |
| Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBN |
| CFR Regulation Number | 864.7300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-26 |
| Decision Date | 1978-11-08 |