Advanced Instruments, LLC
Norwood, MA, US
Advanced Instruments, LLC appears in FDA device records in Norwood, MA. FDA records list 16 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Advanced Instruments, LLC between 1979 and 2016. The busiest year on record is 1979, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1981 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter System | GKL | Substantially Equivalent | |
| K120631 | PATIENT MONITOR | MHX | Substantially Equivalent | |
| K112465 | VITAL SIGNS MONITOR | DQA | Substantially Equivalent | |
| K965036 | THE ADVANCED OSMOMETER (3900) | JJM | Substantially Equivalent | |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | JJM | Substantially Equivalent | |
| K930526 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 | JOW | Substantially Equivalent | |
| K925970 | MODEL 3D3 OSMOMETER | JJM | Substantially Equivalent | |
| K911092 | OSMOMETER MODEL 2400 | JJM | Substantially Equivalent | |
| K873642 | OSMOMETER MODEL 110 | JJM | Substantially Equivalent | |
| K863516 | ELECTRONIC METAL LOCATOR MODEL MD-1 | Substantially Equivalent | ||
| K842784 | CEREGROTRAC | GWQ | Substantially Equivalent | |
| K840385 | VIDEO PRINT | LMC | Substantially Equivalent | |
| K832783 | MICRO-SAMPLE OSMOMETER 3M0 | JJM | Substantially Equivalent | |
| K811840 | BILIRUBINOMETER | JJQ | Substantially Equivalent | |
| K790611 | OSMOMETER MODEL 3W11 | JJM | Substantially Equivalent | |
| K790608 | BL BILIRUBINOMETER | CIG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1217058 | 1217058 | Advanced Instruments, LLC | 2 Technology Way, NORWOOD, MA 02062 US | 2026 | |
| 1221020 | 1221020 | Advanced Instruments, LLC | 25 BRADLEY DR., WESTBROOK, ME 04092 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LMCCamera, Multi Format, Radiological
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
- NNIContainer, Specimen, Non-Sterile
- GKLCounter, Cell, Automated (Particle Counter)
- KZJDevice, Gas Generating
- CIGDiazo Colorimetry, Bilirubin
- KIZDish, Tissue Culture
- GWQFull-Montage Standard Electroencephalograph
- JPKMixture, Hematology Quality Control
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- JJMOsmometer For Clinical Use
- DQAOximeter
- JOWSleeve, Limb, Compressible
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1696-2024 | OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0 | System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls. | Class II | Open, Classified | |
| Z-0640-2019 | GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes. | RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC. | Class II | Terminated | |
| Z-2068-2011 | Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids. | A poorly soldered power cord may pose a potential electrical shock hazard. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain