The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Thrombolytic Activity Test.
| Device ID | K834301 |
| 510k Number | K834301 |
| Device Name: | THROMBOLYTIC ACTIVITY TEST |
| Classification | Test, Thrombin Time |
| Applicant | BIO/DATA CORP. 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 | 1983-12-09 |
| Decision Date | 1984-02-04 |