| K-number | K972638 |
| Device name | TINA-QUANT PREALBUMIN |
| Applicant | Boehringer Mannheim Corp. |
| Product code | JZJ |
| Device class | Class I |
| Decision date | Jan 9, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 866.5060 |
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