The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Tsh Reagent, Calibrator And Control And Au3000i Immunoassay System.
| Device ID | K062581 |
| 510k Number | K062581 |
| Device Name: | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | David Davis |
| Correspondent | David Davis OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | JLW |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2006-11-29 |
| Summary: | summary |