Cala Diagnostics · Class I · Cleared Jul 26, 1991
| K-number | K912826 |
| Device name | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 |
| Applicant | Cala Diagnostics |
| Product code | DKC |
| Device class | Class I |
| Decision date | Jul 26, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 862.3280 |
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