The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Diamond Medica Ise Module Calibrant A Model Me-6370d, Diamond Medica Ise Module Calibrant B, Model Me-5410d.
| Device ID | K093357 |
| 510k Number | K093357 |
| Device Name: | DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D |
| 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 | 2009-10-28 |
| Decision Date | 2010-06-24 |
| Summary: | summary |