The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Fibrogen(fibrin Split Product) Antigen.
| Device ID | K812298 |
| 510k Number | K812298 |
| Device Name: | FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN |
| Classification | Fibrin Split Products |
| Applicant | SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-14 |
| Decision Date | 1981-12-17 |