iC-GPC Assay TM for use on the iC-SystemTM— 510(k) K163390
Substantially EquivalentIcubate, Inc.
FDA 510(k) clearance K163390 for iC-GPC Assay TM for use on the iC-SystemTM, Substantially Equivalent on 2017-08-08. Applicant: Icubate, Inc.. Device class: 2.
Clearance details
- Applicant
- Icubate, Inc.
- Product code
- Code PAM
- 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 PAM
product code PAM- Death
- 6
- Malfunction
- 598
- Total
- 604
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.