Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Advanced Instruments with 16 510(k) clearances and 2 device recalls. The most recent is a device recall dated Mar 11, 2024: OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of free….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 11, 2024 | OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serumClass II · System error messages may delay the ability to test patient samples and the need for frequent calibration due to results | Device recalls |
| Feb 7, 2018 | GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clClass II · RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, | Device recalls |
| May 27, 2016 | Glocyte Automated Cell Counter SystemK152776 · GKL | 510(k) clearances |
| May 25, 2012 | PATIENT MONITORK120631 · MHX | 510(k) clearances |
| Sep 14, 2011 | VITAL SIGNS MONITORK112465 · DQA | 510(k) clearances |
| Feb 20, 1997 | THE ADVANCED OSMOMETER (3900)K965036 · JJM | 510(k) clearances |
| Jul 11, 1996 | ADVANCED MICRO-OSMOMETER MODEL 3300K962056 · JJM | 510(k) clearances |
| Nov 18, 1993 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000K930526 · JOW | 510(k) clearances |
| Jul 9, 1993 | MODEL 3D3 OSMOMETERK925970 · JJM | 510(k) clearances |
| May 22, 1991 | OSMOMETER MODEL 2400K911092 · JJM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
