The following data is part of a premarket notification filed by Response Biomedical Corp. with the FDA for Ramp Troponin I Assay.
| Device ID | K033745 |
| 510k Number | K033745 |
| Device Name: | RAMP TROPONIN I ASSAY |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | RESPONSE BIOMEDICAL CORP. 8081 LOUGHEED HWY. Burnaby, British Columbia, CA V5a 1w9 |
| Contact | William J Radvak |
| Correspondent | William J Radvak RESPONSE BIOMEDICAL CORP. 8081 LOUGHEED HWY. Burnaby, British Columbia, CA V5a 1w9 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-01 |
| Decision Date | 2004-05-17 |
| Summary: | summary |