Medical Device Manufacturer · US , Sunnyvale , CA

Abaxis, Inc.

20 submissions · 20 cleared · Since 1994
20
Total
20
Cleared
0
Denied

Abaxis, Inc. — FDA 510(k) Submissions

Abaxis, Inc. has submitted 20 FDA 510(k) premarket notifications since 1994, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzymatic Esterase--oxidase, Cholesterol, Analyzer, Chemistry, Centrifugal, For Clinical Use, Colorimetric Method, Triglycerides, Photometric Method, Magnesium, System, Test, C-reactive Protein . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
Piccolo Potassium Test System
K200865 · MZV Test, System, Potassium,... · Chemistry
Oct 2021 567d
PICCOLO LACTATE TEST SYSTEM
K130113 · KHP Acid, Lactic, Enzymatic... · Chemistry
Mar 2013 54d
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
K130200 · CHH Enzymatic... · Chemistry
Feb 2013 18d
PICCOLO HDL-CAPILLARY TEST SYSTEM
K120662 · JHM Colorimetric Method,... · Chemistry
Apr 2012 50d
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
K120664 · JGY Colorimetric Method,... · Chemistry
Apr 2012 50d
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
K091052 · DCN System, Test, C-reactive... · Immunology
Jan 2010 277d
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · JGJ Photometric Method,... · Chemistry
Oct 2009 98d
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
K051108 · CFJ Nad Reduction/nadh... · Chemistry
Jul 2005 67d
PICCOLO MAGNESIUM TEST SYSTEM
K040115 · JGJ Photometric Method,... · Chemistry
Jan 2004 10d
PICCOLO TRIGLYCERIDES TEST SYSTEM
K023639 · JGY Colorimetric Method,... · Chemistry
Jan 2003 86d
PICCOLO HDL TEST SYSTEM
K023640 · LBS Ldl & Vldl Precipitation,... · Chemistry
Jan 2003 86d
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
K023642 · CHH Enzymatic... · Chemistry
Jan 2003 86d
PICCOLO PHOSPHORUS TEST SYSTEM
K022312 · CEO Phosphomolybdate... · Chemistry
Sep 2002 50d
PICCOLO CHLORIDE TEST SYSTEM
K010670 · CHJ Mercuric Thiocyanate,... · Chemistry
Apr 2001 51d
PICCOLO SODIUM TEST SYSTEM
K993211 · JGS Electrode, Ion Specific,... · Chemistry
Oct 1999 31d
PICCOLO METLYTE 7 REAGENT DISC
K992140 · JLB Atp And Creatine Kinase... · Chemistry
Aug 1999 63d
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
K955770 · JQB Kinetic Method,... · Chemistry
Sep 1996 263d
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
K950164 · CHH Enzymatic... · Chemistry
Apr 1995 86d
PICCOLO(TM)
K942782 · JJG Analyzer, Chemistry,... · Chemistry
Mar 1995 273d
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
K934592 · JJG Analyzer, Chemistry,... · Chemistry
Apr 1994 194d
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