Piccolo Potassium Test System— 510(k) K200865

Substantially Equivalent

Abaxis, Inc.

FDA 510(k) clearance K200865 for Piccolo Potassium Test System, Substantially Equivalent on 2021-10-20. Applicant: Abaxis, Inc.. Device class: 2.

Clearance details

Applicant: Abaxis, Inc.
Product code: Code MZV
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2020-04-01
Decision date: 2021-10-20
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Union City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MZV

More clearances from Abaxis, Inc.

K130113 — PICCOLO LACTATE TEST SYSTEM2013-03-11
K130200 — PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM2013-02-15
K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM2012-04-24
K120664 — PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM2012-04-24
K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM2010-01-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.