The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Multiquant (r) Quantitative Myoglobin Test.
| Device ID | K982679 |
| 510k Number | K982679 |
| Device Name: | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Contact | Joseph Laurine |
| Correspondent | Joseph Laurine SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-31 |
| Decision Date | 1998-10-07 |
| Summary: | summary |