Medical Device Manufacturer · US

Advanced Instruments, Inc.

16 submissions · 16 cleared · Since 1979
16
Total
16
Cleared
0
Denied

Advanced Instruments, Inc. — FDA 510(k) Submissions

Advanced Instruments, Inc. has submitted 16 FDA 510(k) premarket notifications since 1979, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Osmometer For Clinical Use, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), Counter, Cell, Automated (particle Counter), Diazo Colorimetry, Bilirubin, Colorimeter, Photometer, Spectrophotometer For Clinical Use . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
Glocyte Automated Cell Counter System
K152776 · GKL Counter, Cell, Automated... · Hematology
May 2016 245d
PATIENT MONITOR
K120631 · MHX Monitor, Physiological,... · Cardiovascular
May 2012 85d
VITAL SIGNS MONITOR
K112465 · DQA Oximeter · Anesthesiology
Sep 2011 19d
THE ADVANCED OSMOMETER (3900)
K965036 · JJM Osmometer For Clinical Use · Chemistry
Feb 1997 65d
ADVANCED MICRO-OSMOMETER MODEL 3300
K962056 · JJM Osmometer For Clinical Use · Chemistry
Jul 1996 44d
INTERMITTENT COMPRESSION SYSTEM MODEL 5000
K930526 · JOW Sleeve, Limb, Compressible · Cardiovascular
Nov 1993 289d
MODEL 3D3 OSMOMETER
K925970 · JJM Osmometer For Clinical Use · Chemistry
Jul 1993 226d
OSMOMETER MODEL 2400
K911092 · JJM Osmometer For Clinical Use · Chemistry
May 1991 72d
OSMOMETER MODEL 110
K873642 · JJM Osmometer For Clinical Use · Chemistry
Oct 1987 41d
ELECTRONIC METAL LOCATOR MODEL MD-1
K863516 · General & Plastic Surgery
Sep 1986 21d
CEREGROTRAC
K842784 · GWQ Full-montage Standard... · Neurology
Jan 1985 177d
VIDEO PRINT
K840385 · LMC Camera, Multi Format,... · Radiology
Feb 1984 28d
MICRO-SAMPLE OSMOMETER 3M0
K832783 · JJM Osmometer For Clinical Use · Chemistry
Nov 1983 104d
BILIRUBINOMETER
K811840 · JJQ Colorimeter, Photometer,... · Chemistry
Jul 1981 14d
BL BILIRUBINOMETER
K790608 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jun 1979 78d
OSMOMETER MODEL 3W11
K790611 · JJM Osmometer For Clinical Use · Chemistry
Jun 1979 78d
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