Company ยท US
Advanced Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2016. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJM | Osmometer For Clinical Use | 8 |
| GKL | Counter, Cell, Automated (Particle Counter) | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| DQA | Oximeter | 1 |
| GKE | Osmotic Fragility Testing | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| JOW | Sleeve, Limb, Compressible | 1 |
| LMC | Camera, Multi Format, Radiological | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2016 | K152776 | Glocyte Automated Cell Counter System Advanced Instruments, Inc. | GKL |
| May 25, 2012 | K120631 | PATIENT MONITOR Advanced Instruments, Inc. | MHX |
| Sep 14, 2011 | K112465 | VITAL SIGNS MONITOR Advanced Instruments, Inc. | DQA |
| Feb 20, 1997 | K965036 | THE ADVANCED OSMOMETER (3900) Advanced Instruments, Inc. | JJM |
| Jul 11, 1996 | K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 Advanced Instruments, Inc. | JJM |
| Nov 18, 1993 | K930526 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 Advanced Instruments, Inc. | JOW |
| Jul 9, 1993 | K925970 | MODEL 3D3 OSMOMETER Advanced Instruments, Inc. | JJM |
| May 22, 1991 | K911092 | OSMOMETER MODEL 2400 Advanced Instruments, Inc. | JJM |
| Oct 20, 1987 | K873642 | OSMOMETER MODEL 110 Advanced Instruments, Inc. | JJM |
| Sep 30, 1986 | K863516 | ELECTRONIC METAL LOCATOR MODEL MD-1 Advanced Instruments, Inc. | |
| Jan 10, 1985 | K842784 | CEREGROTRAC Advanced Instruments, Inc. | GWQ |
| Feb 27, 1984 | K840385 | VIDEO PRINT Advanced Instruments, Inc. | LMC |
| Nov 28, 1983 | K832783 | MICRO-SAMPLE OSMOMETER 3M0 Advanced Instruments, Inc. | JJM |
| Jul 15, 1981 | K811840 | BILIRUBINOMETER Advanced Instruments, Inc. | JJQ |
| Jun 15, 1979 | K790611 | OSMOMETER MODEL 3W11 Advanced Instruments, Inc. | JJM |
| Jun 15, 1979 | K790608 | BL BILIRUBINOMETER Advanced Instruments, Inc. | CIG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2024 | Advanced Instruments, LLC 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
Soft Open, Classified |
JJM | None listed |
| Feb 7, 2018 | Advanced Instruments, LLC 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 Terminated |
GKL | K152776 |
| Apr 26, 2011 | Advanced Instruments, Inc. Advanced Instrument Model 2020 Multi-Sample Osmometer
Intended to measure the osmotic pressure of body fluids. Terminated |
GKE | None listed |