Roche Analytical Instruments, Inc. · Class I · Cleared Jun 9, 1980
| K-number | K801119 |
| Device name | COBAS REAGENT FOR ALT (GPT) |
| Applicant | Roche Analytical Instruments, Inc. |
| Product code | CKA |
| Device class | Class I |
| Decision date | Jun 9, 1980 |
| Decision | Substantially Equivalent |
| Regulation | 862.1030 |
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