Olympus America, Inc. · Class II · Cleared Nov 29, 2006
| K-number | K062581 |
| Device name | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM |
| Applicant | Olympus America, Inc. |
| Product code | JLW |
| Device class | Class II |
| Decision date | Nov 29, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 862.1690 |
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