The following data is part of a premarket notification filed by First Medical, Inc. with the FDA for Alpha Dx Analyzer 01-0100, Alpha Dx Myo/ck/ck-mb/tni Cardiac Panel Test Kit 03-0001, Alpha Dx Ck/ck-mb Panel Test Kit.
| Device ID | K974839 |
| 510k Number | K974839 |
| Device Name: | ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | FIRST MEDICAL, INC. 530 LOGUE AVE. Mountain View, CA 94043 |
| Contact | Van N Johnson |
| Correspondent | Van N Johnson FIRST MEDICAL, INC. 530 LOGUE AVE. Mountain View, CA 94043 |
| Product Code | MMI |
| Subsequent Product Code | CGX |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHX |
| Subsequent Product Code | KHO |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-24 |
| Decision Date | 1998-02-04 |
| Summary: | summary |