The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Helena Thromboplastin-mi Reagent.
| Device ID | K940310 |
| 510k Number | K940310 |
| Device Name: | HELENA THROMBOPLASTIN-MI REAGENT |
| Classification | Test, Time, Prothrombin |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-24 |
| Decision Date | 1994-04-20 |