# Infrared Laboratory Systems, LLC (Dba Synermed)

- Location (FDA's records): Westfield, IN
- FDA decisions: 3 (2016–2018): 3 510(k) clearances
- Product codes: JGS (1), CGA (1), DJG (1)
- 510(k) review time since 2016: median 184 days, against 157 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (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
- Synermed, Inc.: 2 (https://510kreport.com/company/synermed)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)
- Lin-Zhi International, Inc.: 1 (https://510kreport.com/company/lin-zhi-international)

## Recent decisions
- K181201: Synermed ISE Reagents (Jul 10, 2018)
- K172416: Synermed Opiate Enzyme Immunoassay (Apr 19, 2018)
- K153692: Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer (Jun 24, 2016)

Source page: https://510kreport.com/company/infrared-laboratory-systems-dba-synermed