The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Spectral's Cardiac Status Ck-mb Rapid Test.
| Device ID | K022409 |
| 510k Number | K022409 |
| Device Name: | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST |
| Classification | Chromatographic Separation, Cpk Isoenzymes |
| 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 | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-24 |
| Decision Date | 2002-09-30 |