PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR— 510(k) K950164

Name: FDA 510(k) clearance K950164
Creator: U.S. Food and Drug Administration
Published: 1995-04-13

Substantially Equivalent

Abaxis, Inc.

FDA 510(k) clearance K950164 for PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR, Substantially Equivalent on 1995-04-13. Applicant: Abaxis, Inc.. Device class: 1.

Clearance details

Applicant: Abaxis, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1995-01-17
Decision date: 1995-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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