FDA applicant

Environmental Test Systems, Inc.

Elkhart, IN8 decisions1997–20035 recalls

FDA records 8 decisions for Environmental Test Systems, Inc. (Elkhart, IN) from 1997 to 2003: 8 510(k) clearances. Most are in product codes MSY (Strip, Test, Reagent, Residuals For Dialysate…) and FKP (System, Dialysate Delivery, Single Patient). 5 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, gastroenterology and urology panel, where it files most

How often FDA has decided Environmental Test Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Environmental Test Systems, Inc. since 2007.

Recalls per year

1in 2009

2007high 4 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Environmental”

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

Environmental Chemical Specialties 15 Environmental Diagnostics, Inc. 6 Environmental Tectonics Corp. 3 Environmental Sciences Assoc., Inc. 2

Environmental Test Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Environmental”