VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
FDA 510(k) clearance K020576 · decided 2002-05-01
Clearance details
- K-number
- K020576
- Device name
- VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
- Applicant
- Id Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-21
- Decision date
- 2002-05-01
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- NIJ
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.