FDA applicant

Universal Reagents, Inc.

Indianapolis, IN8 decisions1996–19970 recalls

FDA records 8 decisions for Universal Reagents, Inc. (Indianapolis, IN) from 1996 to 1997: 8 510(k) clearances. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and GJT (Plasma, Coagulation Factor Deficient). Its devices cite 15 predicates, 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 Universal Reagents, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Universal Reagents, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Universal Reagents, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?