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)

SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER

K-Number: K912494 · 1991-09-10

ApplicantToa Medical Electronics USA, Inc.
Decision Date1991-09-10
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Toa Medical Electronics USA, Inc.. It received FDA 510(k) clearance on 1991-09-10 under 510(k) number K912494. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER?

SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER is a medical device that received FDA 510(k) clearance on 1991-09-10. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K912494.

When did SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER receive FDA 510(k) clearance?

SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER received FDA 510(k) clearance on 1991-09-10, under 510(k) number K912494.

Who is the listed applicant for SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER?

The FDA 510(k) record lists Toa Medical Electronics USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER?

The FDA product code for SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER is GKL.

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 Toa Medical Electronics USA, Inc. 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.

K936023SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZERK933886TOA MEDICAL ELECTRONICS CA-5000K931149CA-1000 AUTOMATED COAGULATION ANALYZERK920544SYSMEX HEMATOLOGY SYSTEM ACCESSORIESK914744SYSMEX NE-1500, MODIFICATIONK911173SYSMEX F-310

View all 33 devices →

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, Inc.

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.

↑