The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Cardioquant Troponin I Test.
| Device ID | K992127 |
| 510k Number | K992127 |
| Device Name: | CARDIOQUANT TROPONIN I TEST |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | SPECTRAL DIAGNOSTICS, INC. 5550 N.W. 102 PLACE Miami, FL 33178 |
| Contact | Francee S Boches |
| Correspondent | Francee S Boches SPECTRAL DIAGNOSTICS, INC. 5550 N.W. 102 PLACE Miami, FL 33178 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-23 |
| Decision Date | 1999-10-04 |
| Summary: | summary |