# Sgm Biotech, Inc.

- Location (FDA's records): Bozeman, MT
- FDA decisions: 4 (1994–2010): 4 510(k) clearances
- Product codes: FRC (4)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgicot, Inc.: 1 (https://510kreport.com/company/surgicot)
- Ati: 1 (https://510kreport.com/company/ati)
- Amsco Co.: 1 (https://510kreport.com/company/amsco)

## Firms that cite its devices most
- STERIS Corporation: 2 (https://510kreport.com/company/steris)
- Raven Biological Laboratories, Inc.: 1 (https://510kreport.com/company/raven-biological-laboratories)
- Spsmedical Supply Corp.: 1 (https://510kreport.com/company/spsmedical-supply)
- Mesa Laboratories, Inc.: 1 (https://510kreport.com/company/mesa-laboratories)

## Its most-cited devices
- K963841: Eztest (1997), cited by 5
- K930682: Eztest-Steam (1994), cited by 2
- K093794: Smart-Read Eztest-Steam Scbi and Test Pack (2010), cited by 1

## Recent decisions
- K093794: Smart-Read Eztest-Steam Scbi and Test Pack (May 14, 2010)
- K091950: Smart-Well Eztest Incubator (Jan 15, 2010)
- K963841: Eztest (Feb 25, 1997)
- K930682: Eztest-Steam (Apr 4, 1994)

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