The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Mission Trinity R (level 1) (level 2) (level 3), (level 1,2,3).
| Device ID | K093384 |
| 510k Number | K093384 |
| Device Name: | MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-30 |
| Decision Date | 2010-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273227123 | K093384 | 000 |
| 05055273227116 | K093384 | 000 |
| 05055273227109 | K093384 | 000 |