# Helmer Labs, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 3 (1977–1981): 3 510(k) clearances
- Product codes: KSQ (2), GLE (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K812533: Platelet Agitator (Sep 29, 1981)
- K802608: Hematic Blood Mixer (Dec 11, 1980)
- K770830: Platelet Agitator (Jul 11, 1977)

Source page: https://510kreport.com/company/helmer-labs