The following data is part of a premarket notification filed by First Medical, Inc. with the FDA for Modification To Alpha Dx System.
| Device ID | K013118 |
| 510k Number | K013118 |
| Device Name: | MODIFICATION TO ALPHA DX SYSTEM |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | FIRST MEDICAL, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland FIRST MEDICAL, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | JHX |
| Subsequent Product Code | DDR |
| Subsequent Product Code | KHO |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-18 |
| Decision Date | 2001-10-15 |