EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR— 510(k) K934592

Name: FDA 510(k) clearance K934592
Creator: U.S. Food and Drug Administration
Published: 1994-04-06

Substantially Equivalent

Abaxis, Inc.

FDA 510(k) clearance K934592 for EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR, Substantially Equivalent on 1994-04-06. Applicant: Abaxis, Inc.. Device class: 1.

Clearance details

Applicant: Abaxis, Inc.
Product code: Code JJG
Device class: Class 1
Regulation: 21 CFR 862.2140
Advisory panel: Clinical Chemistry
Date received: 1993-09-24
Decision date: 1994-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K934592

K-number listed on FDA's recall record

Z-2361-2020 — Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)Class II·Terminated·Abaxis Inc·20191211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934592.

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