The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Mission Olympus Au Ise Calibrators.
| Device ID | K071039 |
| 510k Number | K071039 |
| Device Name: | MISSION OLYMPUS AU ISE CALIBRATORS |
| Classification | Calibrator, Secondary |
| Applicant | DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Kathryn Thorsen |
| Correspondent | Kathryn Thorsen DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-12 |
| Decision Date | 2007-08-08 |
| Summary: | summary |