Chiron Diagnostics Corp. · Class II · Cleared Aug 8, 1997
| K-number | K970695 |
| Device name | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) |
| Applicant | Chiron Diagnostics Corp. |
| Product code | MOI |
| Device class | Class II |
| Decision date | Aug 8, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
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