iC-GN iC-Cassette for use on the iC-System— 510(k) K190341
Substantially EquivalentIcubate, Inc.
FDA 510(k) clearance K190341 for iC-GN iC-Cassette for use on the iC-System, Substantially Equivalent on 2019-06-28. Applicant: Icubate, Inc.. Device class: 2.
Clearance details
- Applicant
- Icubate, Inc.
- Product code
- Code PEN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3365
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntsville, AL, US
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More clearances from Icubate, Inc.
view allAdverse events under product code PEN
product code PEN- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.