The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Bun Reagent For Beckman Synchron Cx & Cx Delta Reagent.
| Device ID | K033056 |
| 510k Number | K033056 |
| Device Name: | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT |
| Classification | Electrode, Ion Specific, Urea Nitrogen |
| Applicant | DIAMOND DIAGNOSTICS, INC. 331 FISKE ST. Holliston, MA 01746 |
| Contact | Linda M Stundtner |
| Correspondent | Linda M Stundtner DIAMOND DIAGNOSTICS, INC. 331 FISKE ST. Holliston, MA 01746 |
| Product Code | CDS |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-01-30 |
| Summary: | summary |