Helena Laboratories · Class II · Cleared Jan 13, 1992
| K-number | K914946 |
| Device name | CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION |
| Applicant | Helena Laboratories |
| Product code | GKP |
| Device class | Class II |
| Decision date | Jan 13, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 864.5400 |
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