The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Troponin-i Test System.
| Device ID | K964862 |
| 510k Number | K964862 |
| Device Name: | TROPONIN-I TEST SYSTEM |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Contact | Radha Goolabsingh |
| Correspondent | Radha Goolabsingh DADE INTL., INC. 2173 NW 99TH AVE. Miami, FL 33172 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-04 |
| Decision Date | 1997-02-10 |
| Summary: | summary |