The following data is part of a premarket notification filed by American Dade with the FDA for Protopath Factor Ix Assay.
| Device ID | K834050 |
| 510k Number | K834050 |
| Device Name: | PROTOPATH FACTOR IX ASSAY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | AMERICAN DADE 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 | 1983-11-23 |
| Decision Date | 1984-02-04 |