# Biotech, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 1 (2014–2014): 1 510(k) clearance
- Product codes: MQK (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 3 (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
- Irvine Scientific Sales Co., Inc.: 1 (https://510kreport.com/company/irvine-scientific-sales)
- Vitrolife Sweden AB: 1 (https://510kreport.com/company/vitrolife-sweden)

## Firms that cite its devices most
- Kitazato Biopharma Co., Ltd.: 1 (https://510kreport.com/company/kitazato-biopharma)
- Reprobitech Corp.: 1 (https://510kreport.com/company/reprobitech)
- Origio A/S: 1 (https://510kreport.com/company/origio-a-s)

## Its most-cited devices
- K122982: Cryolock (2014), cited by 3

## Recent decisions
- K122982: Cryolock (Jan 9, 2014)

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