The following data is part of a premarket notification filed by American Dade with the FDA for Immunoadsorbed Factor X Deficient Plasma (human).
| Device ID | K870353 |
| 510k Number | K870353 |
| Device Name: | IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN) |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen H Darcy |
| Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-29 |
| Decision Date | 1987-02-10 |