Helena Laboratories · Class I · Cleared May 7, 1992
| K-number | K920926 |
| Device name | KEMTROL SERUM CONTROL-ABNORMAL |
| Applicant | Helena Laboratories |
| Product code | JJY |
| Device class | Class I |
| Decision date | May 7, 1992 |
| 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