The following data is part of a premarket notification filed by Nobel Scientific Industries, Inc. with the FDA for Bun Reagent Astra 4 & 8 Analyzers.
| Device ID | K802518 |
| 510k Number | K802518 |
| Device Name: | BUN REAGENT ASTRA 4 & 8 ANALYZERS |
| Classification | Urease, Photometric, Urea Nitrogen |
| Applicant | NOBEL SCIENTIFIC INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDN |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1980-11-12 |