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Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 10

Model 3MA400 · Advanced Instruments, LLC · DI 10816068020990

JMZ — Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality · Class I · 21 CFR 862.1540

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)

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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

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Manufacturer compliance record — Advanced Instruments, LLC

  • VAI 2017-08-04 Advanced Instruments, LLC · 4 citations
  • VAI 2017-08-04 Advanced Instruments, LLC · 4 citations
  • VAI 2012-02-07 Advanced Instruments, LLC · 4 citations
  • VAI 2012-02-07 Advanced Instruments, LLC · 4 citations