The following data is part of a premarket notification filed by American Dade with the FDA for Dade Immu-trace Tri-rac R Tri-level Immunoassay Co.
| Device ID | K850574 |
| 510k Number | K850574 |
| Device Name: | DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-13 |
| Decision Date | 1985-04-12 |