iC-GN iC-Cassette for use on the iC-System
FDA 510(k) clearance K190341 · decided 2019-06-28
Clearance details
- K-number
- K190341
- Device name
- iC-GN iC-Cassette for use on the iC-System
- Applicant
- Icubate, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-14
- Decision date
- 2019-06-28
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- PEN
- Device class
- 2
- Regulation number
- 866.3365
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Huntsville, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.