510(k) Report

FDA applicant

Diagnology, Ltd.

West Cadwell, NJ1 decision1999–19993 recalls

FDA records 1 decision for Diagnology, Ltd. (West Cadwell, NJ) in 1999: 1 510(k) clearance. All are in product code LGC (Enzyme Linked Immunoabsorbent Assay, Herpes…). 3 recalls are linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Diagnology, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnology, Ltd. since 2007.

Recalls per year

1in 2022

2010: 22022: 1
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Diagnology, Ltd. 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?

  • LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific1decision

What has FDA decided for it lately?

  • K983886Pockit HSV 2 Rapid TestDiagnology, Ltd. · 19993 recalls

The one decision as Diagnology, Ltd. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K983886biokitHSV-2 Rapid Test, REF: 300028001Sep 28, 2022Class II
  • K983886Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic…Apr 14, 2010
  • K983886Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test…Apr 14, 2010