MECA XPRESSFISH
FDA 510(k) clearance K140619 · decided 2014-10-10
Clearance details
- K-number
- K140619
- Device name
- MECA XPRESSFISH
- Applicant
- Advandx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-03-11
- Decision date
- 2014-10-10
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- MYI
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.