The following data is part of a premarket notification filed by Response Biomedical Corp. with the FDA for Ramp Nt-probnp Assay.
| Device ID | K063662 |
| 510k Number | K063662 |
| Device Name: | RAMP NT-PROBNP ASSAY |
| Classification | Test, Natriuretic Peptide |
| Applicant | RESPONSE BIOMEDICAL CORP. 100 - 8900 GLENLYON PARKWAY Burnaby, British Columbia, CA V5j 5j8 |
| Contact | Ken Pilgrim |
| Correspondent | Ken Pilgrim RESPONSE BIOMEDICAL CORP. 100 - 8900 GLENLYON PARKWAY Burnaby, British Columbia, CA V5j 5j8 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-08 |
| Decision Date | 2008-07-21 |
| Summary: | summary |