The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Thor Henostatsis Analyzer Cat. No. 1450, 1451.
| Device ID | K961908 |
| 510k Number | K961908 |
| Device Name: | THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-16 |
| Decision Date | 1996-12-10 |