The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Spectral's 2 In 1 (tni-myo).
| Device ID | K020950 |
| 510k Number | K020950 |
| Device Name: | SPECTRAL'S 2 IN 1 (TNI-MYO) |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Contact | Nisar Shaikh |
| Correspondent | Nisar Shaikh SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario, CA M9c1c2 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-25 |
| Decision Date | 2002-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B103A25CS30021 | K020950 | 000 |
| B103A20CS30021 | K020950 | 000 |
| B103A10CS30021 | K020950 | 000 |