Medical Analysis Systems, Inc. · Class I · Cleared Aug 16, 2004
| K-number | K041194 |
| Device name | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H |
| Applicant | Medical Analysis Systems, Inc. |
| Product code | JJX |
| Device class | Class I |
| Decision date | Aug 16, 2004 |
| 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