Helena Laboratories · Class II · Cleared Feb 12, 1993
| K-number | K926222 |
| Device name | OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 |
| Applicant | Helena Laboratories |
| Product code | JPA |
| Device class | Class II |
| Decision date | Feb 12, 1993 |
| Decision | Substantially Equivalent |
| Regulation | 864.5425 |
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