The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Meloy Immunostat Monoclonal Factor Viii.
| Device ID | K841708 |
| 510k Number | K841708 |
| Device Name: | MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | MELOY LABORATORIES, INC. 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 | 1984-04-23 |
| Decision Date | 1984-07-19 |