The following data is part of a premarket notification filed by General Diagnostics with the FDA for Fibri Quik.
| Device ID | K802117 |
| 510k Number | K802117 |
| Device Name: | FIBRI QUIK |
| Classification | Test, Thrombin Time |
| Applicant | GENERAL DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-04 |
| Decision Date | 1980-09-26 |