Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ABX MICROS 60 HEMATOLOGY ANALYZER

K-Number: K014203 · 2002-02-28

ApplicantAbx Diagnostics
Decision Date2002-02-28
Product CodeGKX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABX MICROS 60 HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abx Diagnostics. It received FDA 510(k) clearance on 2002-02-28 under 510(k) number K014203. The device is classified under product code GKX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABX MICROS 60 HEMATOLOGY ANALYZER?

ABX MICROS 60 HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 2002-02-28. The listed applicant is Abx Diagnostics. The 510(k) number is K014203.

When did ABX MICROS 60 HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

ABX MICROS 60 HEMATOLOGY ANALYZER received FDA 510(k) clearance on 2002-02-28, under 510(k) number K014203.

Who is the listed applicant for ABX MICROS 60 HEMATOLOGY ANALYZER?

The FDA 510(k) record lists Abx Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABX MICROS 60 HEMATOLOGY ANALYZER?

The FDA product code for ABX MICROS 60 HEMATOLOGY ANALYZER is GKX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Abx Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030799MICROS 60K030144MODIFICATION TO PENTRA 60 AND PENTRA 60C+K024002PENTRA 80K022200PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120K003677ABX PENTRA 60C+ HEMATOLOGY ANALYZERK002646ABX MICROS CRP

View all 10 devices →

Related Devices (Code: GKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K840948CLEAR POROUS PLASTIC-HYPOALLERGENICGainor Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑