The following data is part of a premarket notification filed by General Diagnostics with the FDA for Thromboquik Thrombin Reagent Prod. #3551.
| Device ID | K800926 |
| 510k Number | K800926 |
| Device Name: | THROMBOQUIK THROMBIN REAGENT PROD. #3551 |
| Classification | Test, Thrombin Time |
| Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-05-08 |