The following data is part of a premarket notification filed by Diamond Diagnostics, Inc with the FDA for Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2.
| Device ID | K120591 |
| 510k Number | K120591 |
| Device Name: | DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 |
| Classification | Calibrator, Secondary |
| Applicant | DIAMOND DIAGNOSTICS, INC 333 Fiske St Holliston, MA 01746 |
| Contact | Kathy Cruz |
| Correspondent | Kathy Cruz 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 | 2012-02-28 |
| Decision Date | 2012-04-17 |
| Summary: | summary |