The following data is part of a premarket notification filed by Elan Diagnostics with the FDA for Atac Pak Bun Reagent.
| Device ID | K021385 |
| 510k Number | K021385 |
| Device Name: | ATAC PAK BUN REAGENT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | ELAN DIAGNOSTICS 1075 W. LAMBERT RD., SUITE D Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking ELAN DIAGNOSTICS 1075 W. LAMBERT RD., SUITE D Brea, CA 92821 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-07-12 |
| Summary: | summary |