Data / Medical devices / United States / Advanced Instruments, LLC
Advanced Instruments, LLC: FDA-registered device maker in Norwood, MA, United States, 2 510(k) clearances
Advanced Instruments, LLC is registered with the FDA (registration 1217058) in Norwood, MA, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 27, 2016. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1217058
- Address
- 2 Technology Way, Norwood, MA, United States, 02062
- Owner or operator
- ADVANCED INSTRUMENTS, LLC (1217058)
- Roles
- Manufacturer
- First device listed
- August 5, 1992
- Registered through
- 2026
- Brand names listed
- 110825-Disposable Tubes and Probe Cleaners, 133800-Micro-Sample Test Kit, 200220-Disposable 12 x 75 Sample Test Tubes, 200223-500 Disposable Sample Tubes, 202825-500 Disposable Micro-Sample Tubes, 240820-20 ?L Pipette, 3LA011-100 mOsm Calibration Standard 10x5mL, 3LA028-Osmolality Linearity Set 100-2000 mOsm/kg 5mL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality | JMZ | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Counter, Cell, Automated (Particle Counter) | GKL | 2 | Manufacturer | accessdata.fda.gov |
| Device, Gas Generating | KZJ | 1 | Manufacturer | accessdata.fda.gov |
| Diazo Colorimetry, Bilirubin | CIG | 2 | Manufacturer | accessdata.fda.gov |
| Dish, Tissue Culture | KIZ | 1 | Manufacturer | accessdata.fda.gov |
| Mixture, Hematology Quality Control | JPK | 2 | Manufacturer | accessdata.fda.gov |
| Osmometer For Clinical Use | JJM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 27, 2016 | K152776 | Glocyte Automated Cell Counter System | GKL | Substantially Equivalent | Advanced Instruments, Inc. | accessdata.fda.gov |
| June 15, 1979 | K790608 | BL BILIRUBINOMETER | CIG | Substantially Equivalent | Advanced Instruments, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 11, 2024 | 94330 | Class II | Ongoing | 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. | accessdata.fda.gov |
| February 7, 2018 | 79584 | Class II | Terminated | 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 labele | 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. | accessdata.fda.gov |
| January 19, 2011 | 58042 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Gas Generating
- All makers of Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
- All makers of Dish, Tissue Culture
- All makers of Diazo Colorimetry, Bilirubin
- All makers of Container, Specimen, Non-Sterile
- All makers of Counter, Cell, Automated (Particle Counter)
Updated April 29, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.