The following data is part of a premarket notification filed by Elan Holdings, Inc. with the FDA for Atac Pak Ast Reagent Kit.
| Device ID | K010488 |
| 510k Number | K010488 |
| Device Name: | ATAC PAK AST REAGENT KIT |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking ELAN HOLDINGS, INC. 231 NORTH PUENTE ST. Brea, CA 92821 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-20 |
| Decision Date | 2001-04-09 |