# Icubate, Inc.

- Location (FDA's records): Huntsville, AL
- FDA decisions: 2 (2017–2019): 2 510(k) clearances
- Product codes: PAM (1), PEN (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nanosphere, Inc.: 2 (https://510kreport.com/company/nanosphere)

## Recent decisions
- K190341: iC-GN iC-Cassette for use on the iC-System (Jun 28, 2019)
- K163390: iC-GPC Assay TM for use on the iC-SystemTM (Aug 8, 2017)

Source page: https://510kreport.com/company/icubate