The following data is part of a premarket notification filed by Id Biomedical Corp. with the FDA for Velogene Rapid Mrsa Identification Assay.
| Device ID | K990640 |
| 510k Number | K990640 |
| Device Name: | VELOGENE RAPID MRSA IDENTIFICATION ASSAY |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Applicant | ID BIOMEDICAL CORP. 8855 NORTHBROOK COURT Burnaby, British Columbia, CA V5j 5j1 |
| Contact | Robert N Bryan |
| Correspondent | Robert N Bryan ID BIOMEDICAL CORP. 8855 NORTHBROOK COURT Burnaby, British Columbia, CA V5j 5j1 |
| Product Code | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-26 |
| Decision Date | 1999-07-09 |
| Summary: | summary |