The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Cardiac Status Controls/troponin I.
| Device ID | K972687 |
| 510k Number | K972687 |
| Device Name: | CARDIAC STATUS CONTROLS/TROPONIN I |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Contact | Francee S Boches |
| Correspondent | Francee S Boches SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-17 |
| Decision Date | 1997-07-28 |