BD GENEOHM VANR ASSAY
FDA 510(k) clearance K102416 · decided 2011-10-20
Clearance details
- K-number
- K102416
- Device name
- BD GENEOHM VANR ASSAY
- Applicant
- Bd Diagnostics Science
- Decision
- Substantially Equivalent
- Date received
- 2010-08-24
- Decision date
- 2011-10-20
- Days to decision
- 422 days
- Clearance type
- Traditional
- Product code
- NIJ
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Xpert vanA (K243405) | Cepheid® | 2024-11-21 |
| IMDX VANR FOR ABBOTT M2000 (K123753) | Intelligent Medical Devices, Inc. | 2013-07-17 |
| Xpert VanA Assay (K092953) | Cepheid | 2009-12-17 |
| IDI-VANR ASSAY (K061686) | Geneohm Sciences Canada, Inc. | 2006-08-30 |
| VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (K020576) | Id Biomedical Corp. | 2002-05-01 |
Recalls involving this device
No recalls on record reference this clearance.