The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Factor Viii Related Antigen Rocket Eid.
| Device ID | K823267 |
| 510k Number | K823267 |
| Device Name: | FACTOR VIII RELATED ANTIGEN ROCKET EID |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | HELENA LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-02 |
| Decision Date | 1982-12-28 |