IMDX C.DIFFICILE FOR ABBOTT M2000— 510(k) K132235
Substantially EquivalentIntelligent Medical Devices, Inc.
FDA 510(k) clearance K132235 for IMDX C.DIFFICILE FOR ABBOTT M2000, Substantially Equivalent on 2013-10-11. Applicant: Intelligent Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Intelligent Medical Devices, Inc.
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
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