The following data is part of a premarket notification filed by Elan Holdings, Inc. with the FDA for Atac Pak Cpk Reagent Kit.
| Device ID | K012474 |
| 510k Number | K012474 |
| Device Name: | ATAC PAK CPK REAGENT KIT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | ELAN HOLDINGS, INC. 1075 W. LAMBERT RD., SUITE D Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking ELAN HOLDINGS, INC. 1075 W. LAMBERT RD., SUITE D Brea, CA 92821 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-02 |
| Decision Date | 2001-10-03 |
| Summary: | summary |