Advanced Instruments, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 16
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1696-2024 | Class II | OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point d | March 11, 2024 |
| Z-0640-2019 | Class II | GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use b | February 7, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152776 | Glocyte Automated Cell Counter System | May 27, 2016 |
| K120631 | PATIENT MONITOR | May 25, 2012 |
| K112465 | VITAL SIGNS MONITOR | September 14, 2011 |
| K965036 | THE ADVANCED OSMOMETER (3900) | February 20, 1997 |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | July 11, 1996 |
| K930526 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 | November 18, 1993 |
| K925970 | MODEL 3D3 OSMOMETER | July 9, 1993 |
| K911092 | OSMOMETER MODEL 2400 | May 22, 1991 |
| K873642 | OSMOMETER MODEL 110 | October 20, 1987 |
| K863516 | ELECTRONIC METAL LOCATOR MODEL MD-1 | September 30, 1986 |
| K842784 | CEREGROTRAC | January 10, 1985 |
| K840385 | VIDEO PRINT | February 27, 1984 |
| K832783 | MICRO-SAMPLE OSMOMETER 3M0 | November 28, 1983 |
| K811840 | BILIRUBINOMETER | July 15, 1981 |
| K790611 | OSMOMETER MODEL 3W11 | June 15, 1979 |
| K790608 | BL BILIRUBINOMETER | June 15, 1979 |