The following data is part of a premarket notification filed by Geneohm Sciences Canada, Inc. with the FDA for Idi-vanr Assay.
| Device ID | K061686 |
| 510k Number | K061686 |
| Device Name: | IDI-VANR ASSAY |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
| Applicant | GENEOHM SCIENCES CANADA, INC. PO BOX 103 Baldwin, MD 21082 |
| Contact | Judi Smith |
| Correspondent | Judi Smith GENEOHM SCIENCES CANADA, INC. PO BOX 103 Baldwin, MD 21082 |
| Product Code | NIJ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-08-30 |
| Summary: | summary |