The following data is part of a premarket notification filed by Response Biomedical Corp. with the FDA for Ramp Myoglobin Assay.
| Device ID | K012040 |
| 510k Number | K012040 |
| Device Name: | RAMP MYOGLOBIN ASSAY |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | RESPONSE BIOMEDICAL CORP. 8855 NORTHBROOK COURT Burnaby, British Columbia, CA V5j 5j1 |
| Contact | William J Radvak |
| Correspondent | William J Radvak RESPONSE BIOMEDICAL CORP. 8855 NORTHBROOK COURT Burnaby, British Columbia, CA V5j 5j1 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-29 |
| Decision Date | 2001-12-18 |
| Summary: | summary |