Boehringer Mannheim Corp. · Class II · Cleared Jul 28, 1997
| K-number | K972513 |
| Device name | TINAQUANT MYOGLOBIN ASSAY |
| Applicant | Boehringer Mannheim Corp. |
| Product code | DDR |
| Device class | Class II |
| Decision date | Jul 28, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 866.5680 |
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