Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

FreezePoint® Freezing Point Osmometer

Model Model 6000P · ELITECHGROUP INC. · DI 03661540304729

JJM — Osmometer For Clinical Use · Class I · 21 CFR 862.2730

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ELITECHGROUP INC.

  • VAI 2025-06-27 ELITechGroup MDX LLC. · 2 citations
  • VAI 2019-02-13 ELITechGroup MDX LLC. · 3 citations
  • VAI 2017-08-11 ELITechGroup, Inc. · 7 citations
  • VAI 2017-08-11 ELITechGroup, Inc. · 7 citations
  • VAI 2015-11-23 ELITechGroup MDX LLC. · 2 citations
  • VAI 2015-05-27 ELITechGroup, Inc. · 3 citations
  • VAI 2015-05-27 ELITechGroup, Inc. · 3 citations
  • VAI 2011-07-22 ELITechGroup, Inc. · 7 citations
  • VAI 2011-07-22 ELITechGroup, Inc. · 7 citations