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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Abaxis, Inc. — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

86 daysmedian FDA review time
277 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200865Piccolo Potassium Test SystemAbaxis, Inc.2021-10-205670
K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.2013-03-11540
K130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMAbaxis, Inc.2013-02-15180
K120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMAbaxis, Inc.2012-04-24500
K120662PICCOLO HDL-CAPILLARY TEST SYSTEMAbaxis, Inc.2012-04-24500
K091052PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEMAbaxis, Inc.2010-01-152770
K091910PICCOLO MAGNESIUM TEST SYSTEMAbaxis, Inc.2009-10-01980
K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.2005-07-08670
K040115PICCOLO MAGNESIUM TEST SYSTEMAbaxis, Inc.2004-01-30100
K023639PICCOLO TRIGLYCERIDES TEST SYSTEMAbaxis, Inc.2003-01-24860
K023642PICCOLO TOTAL CHOLESTEROL TEST SYSTEMAbaxis, Inc.2003-01-24860
K023640PICCOLO HDL TEST SYSTEMAbaxis, Inc.2003-01-24860
K022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.2002-09-05500
K010670PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.2001-04-26510
K993211PICCOLO SODIUM TEST SYSTEMAbaxis, Inc.1999-10-25310
K992140PICCOLO METLYTE 7 REAGENT DISCAbaxis, Inc.1999-08-26632
K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, Inc.1996-09-092630
K950164PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTORAbaxis, Inc.1995-04-13861
K942782PICCOLO(TM)Abaxis, Inc.1995-03-132731
K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENAbaxis, Inc.1994-04-061940

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda