510(k) Report

FDA applicant

Flexsite Diagnostics, Inc.

Washington, DC2 decisions1997–20000 recalls

FDA records 2 decisions for Flexsite Diagnostics, Inc. (Washington, DC) from 1997 to 2000: 2 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and JIR (Indicator Method, Protein Or Albumin (Urinary…). Its devices cite 1 predicate, 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, hematology panel, where it files most

How often FDA has decided Flexsite Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Flexsite Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Flexsite Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LCPAssay, Glycosylated Hemoglobin1decision
  • JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K971919Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc. · 19976cite it

What has FDA decided for it lately?

  • K001810Urisite Urine Collection Kit for Microalbumin/Creatinine TestingFlexsite Diagnostics, Inc. · 2000
  • K971919Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc. · 1997

All 2 as Flexsite Diagnostics, Inc. →