The following data is part of a premarket notification filed by Response Biomedical Corp. with the FDA for Ramp Influenza A/b Assay.
| Device ID | K071591 |
| 510k Number | K071591 |
| Device Name: | RAMP INFLUENZA A/B ASSAY |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| 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 | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-11 |
| Decision Date | 2008-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10627966005244 | K071591 | 000 |
| 10627966005237 | K071591 | 000 |