IMDX C.DIFFICILE FOR ABBOTT M2000
FDA 510(k) clearance K132235 · decided 2013-10-11
Clearance details
- K-number
- K132235
- Device name
- IMDX C.DIFFICILE FOR ABBOTT M2000
- Applicant
- Intelligent Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-18
- Decision date
- 2013-10-11
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- OZN
- Device class
- 2
- Regulation number
- 866.3130
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.