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)

SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN

K-Number: K890349 · 1989-12-29

ApplicantBecton Dickinson Immunocytometry Systems
Decision Date1989-12-29
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Immunocytometry Systems. It received FDA 510(k) clearance on 1989-12-29 under 510(k) number K890349. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN?

SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN is a medical device that received FDA 510(k) clearance on 1989-12-29. The listed applicant is Becton Dickinson Immunocytometry Systems. The 510(k) number is K890349.

When did SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN receive FDA 510(k) clearance?

SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN received FDA 510(k) clearance on 1989-12-29, under 510(k) number K890349.

Who is the listed applicant for SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN?

The FDA 510(k) record lists Becton Dickinson Immunocytometry Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN?

The FDA product code for SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN is GKZ.

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 Becton Dickinson Immunocytometry Systems 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.

K040026BD FACS 7-COLOR SETUP BEADSK040725BD FACSCANTO SYSTEMK980858MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTIONK974360MULTITEST CD3/CD8/CD45/CD4K973483FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SETK971205TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES

View all 21 devices →

Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex 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.

↑