510(k) Report

FDA applicant

Infectio Diagnostic, Inc.

Baldwin, MD1 decision2002–20020 recalls

FDA records 1 decision for Infectio Diagnostic, Inc. (Baldwin, MD) in 2002: 1 510(k) clearance. All are in product code NJR (Nucleic Acid Amplification Assay System, Group…). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Infectio Diagnostic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Infectio Diagnostic, 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?

  • NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1decision

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 2 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.

  • K022504Idi-Strep B AssayInfectio Diagnostic, Inc. · 20022cite it

What has FDA decided for it lately?

  • K022504Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002

The one decision as Infectio Diagnostic, Inc. →

Other applicant names beginning “Infectio”

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

Infectio Diagnostic (I.D.I.), Inc. 2