510(k) Report

FDA applicant

Infrared Laboratory Systems, LLC (Dba Synermed)

Westfield, IN3 decisions2016–20180 recalls

FDA records 3 decisions for Infrared Laboratory Systems, LLC (Dba Synermed) (Westfield, IN) from 2016 to 2018: 3 510(k) clearances. Most are in product codes JGS (Electrode, Ion Specific, Sodium) and CGA (Glucose Oxidase, Glucose). Since 2016 its 510(k)s took a median of 184 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Infrared Laboratory Systems, LLC (Dba Synermed)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2016: 12018: 2
2016high 2 (2018) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Infrared Laboratory Systems, LLC (Dba Synermed) by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JGSElectrode, Ion Specific, Sodium1decision
  • CGAGlucose Oxidase, Glucose1decision
  • DJGEnzyme Immunoassay, Opiates1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 184 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 157 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K181201Synermed ISE ReagentsInfrared Laboratory Systems, LLC (Dba Synermed) · 2018
  • K172416Synermed Opiate Enzyme ImmunoassayInfrared Laboratory Systems, LLC (Dba Synermed) · 2018
  • K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerInfrared Laboratory Systems, LLC (Dba Synermed) · 2016

All 3 as Infrared Laboratory Systems, LLC (Dba Synermed) →

Other applicant names beginning “Infrared”

FDA records each applicant name separately; these may or may not be the same firm.

Infrared Sciences Corp. 1Infrared Imaging Systems, Inc. 1