ABX MICROS 60 HEMATOLOGY ANALYZER— 510(k) K014203

Name: FDA 510(k) clearance K014203
Creator: U.S. Food and Drug Administration
Published: 2002-02-28

Substantially Equivalent

Abx Diagnostics

FDA 510(k) clearance K014203 for ABX MICROS 60 HEMATOLOGY ANALYZER, Substantially Equivalent on 2002-02-28. Applicant: Abx Diagnostics. Device class: 2.

Clearance details

Applicant: Abx Diagnostics
Product code: Code GKX
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 2001-12-21
Decision date: 2002-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKX

view all

K840948 — CLEAR POROUS PLASTIC-HYPOALLERGENIC1984-08-14

More clearances from Abx Diagnostics

view all

K030799 — MICROS 602003-04-08
K030144 — MODIFICATION TO PENTRA 60 AND PENTRA 60C+2003-01-31
K024002 — PENTRA 802003-01-03
K022200 — PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 1202002-07-29
K003677 — ABX PENTRA 60C+ HEMATOLOGY ANALYZER2000-12-26

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