The following data is part of a premarket notification filed by Diamond Diagnostics, Inc with the FDA for Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards.
| Device ID | K133751 |
| 510k Number | K133751 |
| Device Name: | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS |
| 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 | 2013-12-09 |
| Decision Date | 2014-08-08 |
| Summary: | summary |