Medical Device Manufacturer · US , Sunnyvale , CA

Abaxis, Inc. - FDA 510(k) Cleared Devices

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

Abaxis, Inc. has 20 FDA 510(k) cleared chemistry devices. Based in Sunnyvale, US.

Last cleared in 2021. Active since 1994.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Zoetis, LLC (Acquirer of Abaxis, Inc.) as regulatory consultant.

FDA 510(k) Regulatory Record - Abaxis, Inc.
20 devices
1-20 of 20
Cleared Oct 20, 2021
Piccolo Potassium Test System
K200865 · MZV
Chemistry · 567d
Cleared Mar 11, 2013
PICCOLO LACTATE TEST SYSTEM
K130113 · KHP
Chemistry · 54d
Cleared Feb 15, 2013
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
K130200 · CHH
Chemistry · 18d
Cleared Apr 24, 2012
PICCOLO HDL-CAPILLARY TEST SYSTEM
K120662 · JHM
Chemistry · 50d
Cleared Apr 24, 2012
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
K120664 · JGY
Chemistry · 50d
Cleared Jan 15, 2010
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
K091052 · DCN
Immunology · 277d
Cleared Oct 01, 2009
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · JGJ
Chemistry · 98d
Cleared Jul 08, 2005
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
K051108 · CFJ
Chemistry · 67d
Cleared Jan 30, 2004
PICCOLO MAGNESIUM TEST SYSTEM
K040115 · JGJ
Chemistry · 10d
Cleared Jan 24, 2003
PICCOLO TRIGLYCERIDES TEST SYSTEM
K023639 · JGY
Chemistry · 86d
Cleared Jan 24, 2003
PICCOLO HDL TEST SYSTEM
K023640 · LBS
Chemistry · 86d
Cleared Jan 24, 2003
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
K023642 · CHH
Chemistry · 86d
Cleared Sep 05, 2002
PICCOLO PHOSPHORUS TEST SYSTEM
K022312 · CEO
Chemistry · 50d
Cleared Apr 26, 2001
PICCOLO CHLORIDE TEST SYSTEM
K010670 · CHJ
Chemistry · 51d
Cleared Oct 25, 1999
PICCOLO SODIUM TEST SYSTEM
K993211 · JGS
Chemistry · 31d
Cleared Aug 26, 1999
PICCOLO METLYTE 7 REAGENT DISC
K992140 · JLB
Chemistry · 63d
Cleared Sep 09, 1996
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
K955770 · JQB
Chemistry · 263d
Cleared Apr 13, 1995
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
K950164 · CHH
Chemistry · 86d
Cleared Mar 13, 1995
PICCOLO(TM)
K942782 · JJG
Chemistry · 273d
Cleared Apr 06, 1994
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR
K934592 · JJG
Chemistry · 194d
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