American Dade · Class I · Cleared Feb 7, 1983
| K-number | K823352 |
| Device name | IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS |
| Applicant | American Dade |
| Product code | JJY |
| Device class | Class I |
| Decision date | Feb 7, 1983 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov