The following data is part of a premarket notification filed by Elan Holdings, Inc. with the FDA for Atac Pak Bun Reagent And Atac Calibrator Kits.
| Device ID | K000958 |
| 510k Number | K000958 |
| Device Name: | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. Brea, CA 92821 |
| Contact | Wynn Stoking |
| Correspondent | Wynn Stoking ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. 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 | 2000-03-24 |
| Decision Date | 2000-05-24 |