The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Porcine Factor Viii;c Reagent.
| Device ID | K952321 |
| 510k Number | K952321 |
| Device Name: | PORCINE FACTOR VIII;C REAGENT |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1996-03-11 |