# Hana Biologics, Inc.

- Location (FDA's records): Walker, MI
- FDA decisions: 8 (1981–1988): 8 510(k) clearances
- Product codes: JSI (3), KIT (2), JHG (2), KQN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Irvine Scientific Sales Co., Inc.: 1 (https://510kreport.com/company/irvine-scientific-sales)

## Its most-cited devices
- K822150: Amnistat-FLM (1982), cited by 1

## Recent decisions
- K883682: Chang Medium (Additional Indications) (Sep 16, 1988)
- K855205: Mycotrim TM VL Triphasic Culture System (Feb 5, 1986)
- K834616: Amnio Stat-FLM Agglutination Test (May 25, 1984)
- K833933: Ace Color Test (Mar 23, 1984)
- K822736: Mycotrium-GU (Dec 3, 1982)
- K822737: Mycotrium-RS (Dec 3, 1982)
- K822150: Amnistat-FLM (Oct 21, 1982)
- K812820: Chang Medium (Nov 10, 1981)

Source page: https://510kreport.com/company/hana-biologics