The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Spectral Cardiac Status Ck-mb/myoglobin/troponin I 3-in-1 Test.
| Device ID | K030057 |
| 510k Number | K030057 |
| Device Name: | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Contact | Nisar A Shaikh |
| Correspondent | Nisar A Shaikh SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Product Code | MMI |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-07 |
| Decision Date | 2003-03-19 |