The following data is part of a premarket notification filed by Response Biomedical Corp. with the FDA for Ramp Rsv Assay.
| Device ID | K091235 |
| 510k Number | K091235 |
| Device Name: | RAMP RSV ASSAY |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | RESPONSE BIOMEDICAL CORP. 1781 - 75TH AVENUE W. Vancouver, B.c, CA V6p 6p2 |
| Contact | Ken Pilgrim |
| Correspondent | Ken Pilgrim RESPONSE BIOMEDICAL CORP. 1781 - 75TH AVENUE W. Vancouver, B.c, CA V6p 6p2 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-07-24 |
| Summary: | summary |