510(k) Report

FDA applicant

Chembio Diagnostic Systems, Inc.

Beverly, MA7 decisions1992–20201 recall

FDA records 7 decisions for Chembio Diagnostic Systems, Inc. (Beverly, MA) from 1992 to 2020: 7 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Chembio Diagnostic Systems”.

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 Chembio Diagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Chembio Diagnostic Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JHIVisual, Pregnancy Hcg, Prescription Use2decisions
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter2decisions
  • LSRReagent, Borrelia Serological Reagent1decision
  • QFOZika Virus Serological Reagents1decision
  • CEPRadioimmunoassay, Luteinizing Hormone1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K923925HCG Stat-PakChembio Diagnostic Systems, Inc. · 19921cites it

What has FDA decided for it lately?

  • K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderChembio Diagnostic Systems · 2020
  • K011550HCG Stat Pak Ultra-FastChembio Diagnostic Systems, Inc. · 2001
  • K011551Sure Check Pregnancy TestChembio Diagnostic Systems, Inc. · 2001
  • K010244Sure Check Ovulation PredictorChembio Diagnostic Systems, Inc. · 2001
  • K981913Prevue (TM) Borrelia Burgdorferi Antibody Detection AssayChembio Diagnostic Systems, Inc. · 1999
  • K961965Sure Check Pregnancy TestChembio Diagnostic Systems, Inc. · 19961 recall
  • K923925HCG Stat-PakChembio Diagnostic Systems, Inc. · 1992

All 6 as Chembio Diagnostic Systems, Inc. →The one decision as Chembio Diagnostic Systems →

What has been recalled?

1 recall linked to its devices; the latest:

  • K961965OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the…Oct 6, 2004