The following data is part of a premarket notification filed by Id Biomedical Corp. with the FDA for Velogene Genomic Identification Assay For Mrsa With One-step Detection.
| Device ID | K010858 |
| 510k Number | K010858 |
| Device Name: | VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Applicant | ID BIOMEDICAL CORP. 19204 N. CREEK PKWAY., STE 100 Bothell, WA 98011 |
| Contact | David Clary |
| Correspondent | David Clary ID BIOMEDICAL CORP. 19204 N. CREEK PKWAY., STE 100 Bothell, WA 98011 |
| Product Code | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-22 |
| Decision Date | 2001-05-24 |