510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K014203Substantially Equivalent

Abx Micros 60 Hematology Analyzer

Horiba Instruments Incorporated, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014203 is the FDA 510(k) clearance record for ABX MICROS 60 HEMATOLOGY ANALYZER, a class II device, cleared for Abx Diagnostics on under FDA product code GKX (Instrument, Automated Platelet Counting). FDA records list 89 510(k) clearances for HORIBA INSTRUMENTS INCORPORATED, from to . As of , FDA records show no recalls naming K014203.

Clearance record

Decision date
Received
(69 days to decision)
Product code
GKX Instrument, Automated Platelet Counting
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Abx Diagnostics 34 Bunsen Dr., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code GKX

Trailing 12 months

FDA records hold no clearances under product code GKX in the trailing twelve months.

FDA records show no clearances under product code GKX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GKX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260