The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Cardiac Status Controls (ck-mb/myoglobin/troponin I).
| Device ID | K981474 |
| 510k Number | K981474 |
| Device Name: | CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Contact | Joseph Laurino |
| Correspondent | Joseph Laurino SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-24 |
| Decision Date | 1998-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B103CSC30231 | K981474 | 000 |