The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Total Protein Reagent Tp.
| Device ID | K845052 |
| 510k Number | K845052 |
| Device Name: | PARAMAX TOTAL PROTEIN REAGENT TP |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | James E Keller |
| Correspondent | James E Keller AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-15 |
| Decision Date | 1984-04-13 |