Helena Laboratories · Class II · Cleared Oct 1, 1985
| K-number | K852391 |
| Device name | EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE |
| Applicant | Helena Laboratories |
| Product code | CFH |
| Device class | Class II |
| Decision date | Oct 1, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 862.1440 |
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