Clinical Chemistry— FDA advisory panel CH

Clinical chemistry is the in-vitro diagnostics workhorse panel: automated chemistry analyzers, blood glucose meters and their test strips, blood gas and electrolyte systems, and the individual assay kits — enzymes, metabolites, therapeutic analytes — that run on them. Its high product-code count reflects how the IVD classification works: each analyte family tends to carry its own code, so a single analyzer ecosystem touches dozens of codes.

When reading clearances here, note that the device isn't always the instrument — more often it's a reagent system or test kit cleared for use on a named platform. Glucose monitoring deserves special mention as the panel's consumer-visible edge: meters and strips for over-the-counter use clear through this panel, and their filings are a useful window into the diabetes-tech market's cadence.